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All2,108 Food523 Consumer310 Drug357 Devices918
457 recalls match
Drug Recall
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro…
SUN PHARMACEUTICAL INDUSTRIES
Updated Aug 3 1968 Bottles (1000Tablets/Bottl… units
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Drug Recall
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only…
Supernus Pharmaceuticals
Updated Aug 31 11304 bottles units
Failed dissolution specifications.
Drug Recall
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single…
MYCOPHENOLATE MOFETIL
Updated Aug 26 11,336 units units
Failed Dissolution Specifications
Drug Recall
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by…
FLUPHENAZINE HYDROCHLORIDE
Updated Aug 25 403,200 tablets units
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term s…
Drug Recall
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500…
RAMIPRIL
Updated Aug 24 a) 25,970 bottles; b) 2,384 bot… units
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Drug Recall
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in…
TRAZODONE HYDROCHLORIDE
Updated Aug 24 175,392 bottles units
Presence of Foreign Tablets/Capsules
Drug Recall
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS…
PRASUGREL
Updated Aug 21 6791 30-count bottles units
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
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Drug Recall
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC…
CHLORHEXIDINE GLUCONATE
Updated Aug 18 165,536 packages units
Cross Contamination with Other Products
Drug Recall
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per…
SODIUM CHLORIDE
Updated Aug 17 145,464 500mL bags units
Presence of particulate matter: Particulates identified as fiberglass
Drug Recall
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%…
Allies Group
Updated Aug 14 23,941, 20mL-Tube units
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Drug Recall
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%…
Allies Group
Updated Aug 14 29,014 50mL Tubes units
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Drug Recall
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%…
Allies Group
Updated Aug 14 2,149 90mL-Tubes units
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Drug Recall
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%…
Allies Group
Updated Aug 14 27,492 3mL Sachets units
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Drug Recall
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only…
TYENNE
Updated Aug 10 4,643 20mL-vials units
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Drug Recall
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20…
Church & Dwight
Updated Aug 10 318,600 cartons units
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Drug Recall
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count…
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Updated Aug 7 14,232 bottles (1,423,200 table… units
Presence of Foreign Tablets/Capsules
Drug Recall
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes…
MORPHINE SULFATE
Updated Aug 4 625500 syringes units
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Drug Recall
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only"…
Shoolin Pharma Chem LLP
Updated Aug 3 1KG - 20 X 1KG(1000gm) bags units
CGMP Deviations:Noted during FDA inspection
Drug Recall
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding…
Shoolin Pharma Chem LLP
Updated Aug 3 25 KG, 25 X 1.00 KG bags units
CGMP Deviations:Noted during FDA inspection
Drug Recall
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding…
Shoolin Pharma Chem LLP
Updated Aug 3 20 KG, 40 X 0.500KG(500gm) bags units
CGMP Deviations:Noted during FDA inspection
Drug Recall
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only"…
Shoolin Pharma Chem LLP
Updated Aug 3 1KG - 100-0.1KG(100gm) bags units
CGMP Deviations:Noted during FDA inspection
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Drug Recall
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription…
Shoolin Pharma Chem LLP
Updated Aug 3 25KG, 250-1gm bags units
CGMP Deviations:Noted during FDA inspection
Drug Recall
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound…
OPTIRAY
Updated Jul 31 3,486 500mL-vials units
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Drug Recall
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist…
Prestige Brands Holdings
Updated Jul 29 39,060 15mL-bottles units
Lack of assurance of sterility. The recall is due to potential contamination
Drug Recall
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only…
PEMRYDI RTU
Updated Jul 29 9,489 50mL vials units
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Drug Recall
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only…
PEMRYDI RTU
Updated Jul 29 18,434 10mL vials units
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Drug Recall
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC…
TRALEMENT
Updated Jul 24 323,000 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL…
CYANOCOBALAMIN
Updated Jul 24 235,350 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Drug Recall
ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION…
ACETYLCYSTEINE
Updated Jul 24 316,450 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION…
ACETYLCYSTEINE
Updated Jul 24 169,200 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL…
MULTRYS
Updated Jul 24 185,775 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a…
DABIGATRAN ETEXILATE
Updated Jul 16 3,600 cartons x 6 x 10 (in blis… units
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and To…
Drug Recall
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a…
DABIGATRAN ETEXILATE
Updated Jul 16 936 cartons x 12 x 3 x 10 (in b… units
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and To…
Drug Recall
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a…
DABIGATRAN ETEXILATE
Updated Jul 16 924 cartons x 12 x 6 x 10 (in b… units
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and To…
Drug Recall
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5…
LIDOCAINE
Updated Jul 16 181,225 vials units
Presence of Particulate Matter: Hair was found in products
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Drug Recall
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%…
ROHTO OPTIC GLOW
Updated Jul 14 1,278,457 cartons units
Lack of Assurance of Sterility
Drug Recall
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80…
ROHTO
Updated Jul 14 499,673 cartons units
Lack of Assurance of Sterility
Drug Recall
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80…
ROHTO
Updated Jul 14 2910148 cartons units
Lack of Assurance of Sterility
Drug Recall
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90…
ROHTO
Updated Jul 14 6076306 cartons units
Lack of Assurance of Sterility
Drug Recall
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc…
Rohto-Mentholatum (Vietnam)
Updated Jul 14 1.033,266 cartons units
Lack of Assurance of Sterility
Drug Recall
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jul 9 43,066,599 units units
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Drug Recall
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.)…
CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID
Updated Jun 25 106,301 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Drug Recall
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique…
CETIRIZINE HYDROCHLORIDE
Updated Jun 24 34,020 100-count bottles. units
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydro…
Drug Recall
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube…
NYSTATIN
Updated Jun 23 180,936 tubes units
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Drug Recall
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries…
PERAMPANEL
Updated Jun 17 3,456 30-count bottles units
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Drug Recall
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline…
MEDLINE
Updated Jun 11 509,652 tubes units
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Drug Recall
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol…
CHLORAPREP ONE-STEP
Updated Jun 11 146,600 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC…
PREDNISOLONE ACETATE
Updated Jun 4 2,530,182 bottles units
Presence of Foreign Substance
Drug Recall
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC…
CORLANOR
Updated Jun 4 934577 bottles units
Presence of Foreign Substance.
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Drug Recall
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt…
LACOSAMIDE
Updated Jun 4 31,392 60-count bottles units
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100m…
Drug Recall
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346…
POVI-ONE
Updated Jun 4 8132 6-packs & 2262 2-packs units
sub potency
Drug Recall
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC…
DULOXETINE
Updated Jun 4 359,676 bottles units
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Drug Recall
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal…
PRIMIDONE
Updated Jun 3 27,936 100-count bottles units
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufact…
Drug Recall
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated May 28 178,000 applicators units
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding whic…
Drug Recall
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol…
CHLORAPREP ONE-STEP
Updated May 28 193,440 applicators units
Non-Sterility: Due to presence of Aspergillus penicillioides.
Drug Recall
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx…
LIDOLOG KIT
Updated May 18 168,300 vials units
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
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Drug Recall
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake…
EPINEPHRINE
Updated May 14 898,050 vials units
Failed Impurities/Degradations Specifications
Drug Recall
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by…
NICOTINE
Updated May 14 59,808 pouches (4,272 Individua… units
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during s…
Drug Recall
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by…
LIDOCAINE HYDROCHLORIDE
Updated May 12 210625 ampules units
Lack of Assurance of Sterility
Drug Recall
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ…
Haleon US Holdings
Updated May 11 285,330 blister cards units
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Drug Recall
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY…
CIMZIA
Updated May 8 141,708 cartons units
Lack of Assurance of Sterility
Drug Recall
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle…
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Updated May 5 15,696 x 30's bottles units
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Drug Recall
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only…
BUSULFAN
Updated May 4 Lot 656412: 6,200 vials. Lot 65… units
Failed Impurities/Degradation Specifications
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Drug Recall
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx…
PRIMIDONE
Updated May 1 225,000 tablets units
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Drug Recall
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta…
DULOXETINE
Updated Apr 29 117,168 packs units
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month…
Drug Recall
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b)…
DULOXETINE
Updated Apr 29 312,894 packs units
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month…
Drug Recall
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx…
METOPROLOL SUCCINATE
Updated Apr 27 17,304 100-count bottles units
Failed Dissolution Specifications
Drug Recall
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin…
LIRAGLUTIDE
Updated Apr 24 217,621 pen injectors units
Presence of particulate matter: a white thread-like structure in the cartridge
Drug Recall
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa…
DULOXETINE
Updated Apr 21 165,761 90-count bottles units
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Drug Recall
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister…
OMEGA-3-ACID ETHYL ESTERS
Updated Apr 9 2,238 5 x 10 unit dose cartons units
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
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Drug Recall
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical…
SODIUM CHLORIDE FOR IRRIGATION
Updated Apr 2 124,244 bags units
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Drug Recall
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only…
LIDOCAINE HYDROCHLORIDE
Updated Apr 2 33,599,925 ampules and 23658125… units
Lack of Assurance of Sterility
Drug Recall
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL)…
BUPIVACAINE HYDROCHLORIDE
Updated Apr 2 3,260,170 ampules units
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative…
SODIUM CHLORIDE
Updated Apr 2 7,120,750 ampules units
Lack of Assurance of Sterility
Drug Recall
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for…
PRAZOSIN HYDROCHLORIDE
Updated Mar 27 58,896 bottles- 100's count units
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Drug Recall
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for…
PRAZOSIN HYDROCHLORIDE
Updated Mar 27 88,008 bottles- 100's count units
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Drug Recall
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for…
PRAZOSIN HYDROCHLORIDE
Updated Mar 27 28,157 bottles- 100's count units
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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Drug Recall
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only…
PANTOPRAZOLE SODIUM
Updated Mar 26 4,740 1,000-count bottles. units
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Drug Recall
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc…
FLUOCINONIDE
Updated Mar 25 41,712 30g tubes units
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Drug Recall
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc…
FLUOCINONIDE
Updated Mar 25 24,672 15 g tubes units
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Drug Recall
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc…
FLUOCINONIDE
Updated Mar 25 2,640 60g tubes units
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Drug Recall
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by…
OMNIPAQUE
Updated Mar 24 306,810 vials units
Presence of particulate matter
Drug Recall
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by…
OMNIPAQUE
Updated Mar 24 866,570 vials units
Presence of particulate matter
Drug Recall
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4…
CLONIDINE TRANSDERMAL SYSTEM
Updated Mar 19 113,943 Cartons units
CGMP Deviations: use of an unapproved raw material
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Drug Recall
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4…
CLONIDINE TRANSDERMAL SYSTEM
Updated Mar 19 124,054 Cartons units
CGMP Deviations: use of an unapproved raw material
Drug Recall
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in…
MAGNESIUM SULFATE
Updated Mar 18 784 (12x100mL) cartons units
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid…
Drug Recall
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile…
Nephron SC
Updated Mar 17 146,280 vials units
Labelling: Illegible label
Drug Recall
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by…
CINACALCET
Updated Mar 16 113,336 bottles units
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Drug Recall
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only…
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Updated Mar 5 107,136 vials units
Lack of Assurance of Sterility
Drug Recall
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl…
GNP EYE DROPS REDNESS AND DRY EYE RELIEF
Updated Mar 3 315,144 bottles units
Lack of Assurance of Sterility
Drug Recall
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400…
ARTIFICIAL TEARS
Updated Mar 3 1,023,096 bottles units
Lack of Assurance of Sterility
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Drug Recall
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL)…
GOODSEN EYE DROPS ORIGINAL FORMULA
Updated Mar 3 378,144 bottles units
Lack of Assurance of Sterility
Drug Recall
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5…
LEADER ULTRA LUBRICATING EYE DROPS
Updated Mar 3 245,184 bottles units
Lack of Assurance of Sterility
Drug Recall
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5…
LEADER ARTIFICIAL TEARS 15 ML
Updated Mar 3 589,848 bottles units
Lack of Assurance of Sterility
Drug Recall
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15…
QUALITY CHOICE EYE DROPS IRRITATION RELIEF
Updated Mar 3 182,424 bottles units
Lack of Assurance of Sterility
Drug Recall
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and…
QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS
Updated Mar 3 303,216 bottles units
Lack of Assurance of Sterility
Drug Recall
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by…
NILOTINIB
Updated Feb 18 271 cartons - Ex: 84 outer cart… units
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by…
Drug Recall
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl…
OurPharma
Updated Sep 3 1,610 bags units
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2…
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Drug Recall
Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate…
Lexia
Updated Aug 21 1,200 4 oz-Jar units
CGMP Deviations: Potential contamination of raw material
Drug Recall
Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg…
Lexia
Updated Aug 21 2,400 2 oz-jars units
CGMP Deviations: Potential contamination of raw material
Drug Recall
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed…
BUPRENORPHINE
Updated Aug 19 10,953 cartons. units
Labeling: Label Mix-up
Drug Recall
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…
PRASUGREL
Updated Aug 17 47,662 bottles units
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Drug Recall
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun…
LACTATED RINGERS
Updated Aug 12 23,688 bags units
Presence of Particulate matter.
Drug Recall
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd…
ACTHAR
Updated Aug 6 12367 vials units
Presence of particulate matter: glass and stopper piece
Drug Recall
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous…
Apollo Care
Updated Jul 29 24,608 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drug Recall
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous…
Apollo Care
Updated Jul 29 37,546 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous…
Apollo Care
Updated Jul 29 23,029 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous…
Apollo Care
Updated Jul 29 56,918 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion…
LIBTAYO
Updated Jul 28 21,353 vials units
Lack of Assurance of Sterility
Drug Recall
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in…
Baxter Healthcare
Updated Jul 24 19,032 bags units
Presence of Particulate Matter
Drug Recall
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in…
SELENIOUS ACID
Updated Jul 24 41,680 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE…
AMINOCAPROIC ACID
Updated Jul 24 63,200 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Drug Recall
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL…
NICARDIPINE HYDROCHLORIDE
Updated Jul 24 43,460 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC…
NITROGLYCERIN
Updated Jul 24 98,200 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1…
ATROPINE SULFATE
Updated Jul 24 89,775 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial…
PAPAVERINE HYDROCHLORIDE
Updated Jul 24 86,100 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Drug Recall
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only…
CYANOCOBALAMIN
Updated Jul 24 26,450 vials units
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Drug Recall
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL…
GLYCOPYRROLATE
Updated Jul 16 59,425 vials units
Presence of Particulate Matter: Hair was found in product
Drug Recall
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25…
XYLOCAINE
Updated Jul 16 37,250 vials units
Presence of Particulate Matter: Hair was found in products
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Drug Recall
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25…
XYLOCAINE
Updated Jul 16 93,250 vials units
Presence of Particulate Matter: Hair was found in products
Drug Recall
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL)…
NAROPIN
Updated Jul 16 92,600 vials units
Presence of Particulate Matter: Hair was found in products
Drug Recall
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL…
ROHTO DRY-AID
Updated Jul 14 97201 cartons units
Lack of Assurance of Sterility
Drug Recall
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%)…
ROHTO DIGI-EYE
Updated Jul 14 65219 cartons units
Lack of Assurance of Sterility
Drug Recall
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only…
CYPROHEPTADINE HYDROCHLORIDE
Updated Jul 13 74208 units units
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Drug Recall
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only…
TROKENDI XR
Updated Jul 6 15,853 bottles units
Failed Dissolution Specifications
Drug Recall
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use…
CLEVIPREX
Updated Jul 6 44280 vials units
Lack of Assurance of Sterility
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Drug Recall
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla…
CINACALCET
Updated Jun 29 31,824 bottles units
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Drug Recall
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01…
Bell Pharmaceuticals
Updated Jun 25 31,094 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb…
GOOD NEIGHBOR PHARMACY EARWAX REMOVAL
Updated Jun 25 20, 160 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS…
TOPCARE EARWAX REMOVAL KIT
Updated Jun 25 16,156 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included…
FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB
Updated Jun 25 11, 977 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL)…
CLINERE EAR WAX REMOVER
Updated Jun 25 29, 474 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included…
QUALITY CHOICE EARWAX REMOVAL KIT
Updated Jun 25 15, 843 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Drug Recall
Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous…
Reliance Life Sciences Private
Updated Jun 24 12,000 vials units
Lack of Sterility Assurance
Drug Recall
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or…
Reliance Life Sciences Private
Updated Jun 24 11,400 vials units
Lack of Sterility Assurance
Drug Recall
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial…
GLUCAGON
Updated Jun 23 64,894 units units
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Drug Recall
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx…
BUPRENORPHINE HYDROCHLORIDE
Updated Jun 12 46,334 units units
Crystallization; identified as Buprenorphine free base
Drug Recall
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 10,500 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 18,000 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only…
CHLORTHALIDONE
Updated Jun 5 11,460 bottles units
Failed Dissolution Specifications
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Drug Recall
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3…
Haleon US Holdings
Updated Jun 4 35,883 boxes/carton units
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Drug Recall
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only…
DULOXETINE
Updated Jun 4 14,729 bottles. units
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Drug Recall
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx…
MINOCYCLINE HYDROCHLORIDE
Updated Jun 1 360 30-count bottles units
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Drug Recall
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx…
PRIMIDONE
Updated May 1 63,500 tablets units
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Drug Recall
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus…
ERYTHROMYCIN
Updated Apr 29 23,880 bottles units
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Drug Recall
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus…
ERYTHROMYCIN
Updated Apr 29 10,992 bottles units
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Drug Recall
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta…
DULOXETINE
Updated Apr 29 77,376 packs. units
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month…
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Drug Recall
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc…
LACTATED RINGERS
Updated Apr 28 95,412 containers units
Presence of Particulate Matter.
Drug Recall
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company…
PRIMIDONE
Updated Apr 24 44865 bottles units
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Drug Recall
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN…
Harrow Eye
Updated Apr 17 50,900 units units
Lack of Assurance of Sterility
Drug Recall
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For…
LEVOCARNITINE
Updated Apr 16 74,040 Single Dose Vials units
Labeling: Missing Label
Drug Recall
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by…
BUSPIRONE HYDROCHLORIDE
Updated Apr 13 10,875 Bottles units
Subpotent drug
Drug Recall
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured…
TERPENICOL
Updated Apr 8 22,143 bottles units
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Drug Recall
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By…
Blaine Labs
Updated Apr 8 26,475 bottles units
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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Drug Recall
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL)…
Blaine Labs
Updated Apr 8 1,171 - 1 oz bottles units
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Drug Recall
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET…
Water-Jel Technologies
Updated Apr 7 31,488 tubes units
Failed PH Specifications
Drug Recall
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for…
Fresenius Medical Care Holdings
Updated Apr 6 37,215 bags units
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Drug Recall
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for…
Fresenius Medical Care Holdings
Updated Apr 6 43,225 bags units
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Drug Recall
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun…
STERILE WATER
Updated Apr 2 24,928 bags units
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Drug Recall
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc…
LACTATED RINGERS IRRIGATION
Updated Apr 2 54,540 bags units
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Drug Recall
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc…
DEXTRO
Updated Apr 2 17,124 bags units
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Drug Recall
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of…
Wells Pharma of Houston
Updated Apr 1 13,070 IV Bags units
cGMP deviations.
Drug Recall
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION…
EPINEPHRINE
Updated Apr 1 81,520 units units
Lack of Assurance of Sterility
Drug Recall
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script…
Island Kinetics d.b.a. CoValence Laboratories
Updated Apr 1 28,163 bottles units
Failed Stability Specifications
Drug Recall
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron…
Fagron Compounding Services
Updated Mar 20 16,130 bags units
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Drug Recall
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron…
Fagron Compounding Services
Updated Mar 20 34,260 bags units
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Drug Recall
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron…
Fagron Compounding Services
Updated Mar 20 25,260 bags units
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Drug Recall
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron…
Fagron Compounding Services
Updated Mar 20 11,680 bags units
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Drug Recall
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4…
CLONIDINE TRANSDERMAL SYSTEM
Updated Mar 19 62,136 Cartons units
CGMP Deviations: use of an unapproved raw material
Drug Recall
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by…
TRAMADOL HYDROCHLORIDE
Updated Mar 19 29,542 bottles units
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month …
Drug Recall
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg…
OCTREOTIDE ACETATE
Updated Mar 17 21,930 Cartons units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Drug Recall
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg…
OCTREOTIDE ACETATE
Updated Mar 17 19,869 Cartons units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Drug Recall
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by…
CINACALCET
Updated Mar 16 96,096 bottles units
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Drug Recall
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by…
CINACALCET
Updated Mar 16 63,192 bottles units
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Drug Recall
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only…
BUPRENORPHINE HYDROCHLORIDE
Updated Mar 13 34,293 vials units
Crystallization; identified as Buprenorphine free base
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Drug Recall
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety…
LANREOTIDE ACETATE
Updated Mar 13 54,583 syringes units
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection pr…
Drug Recall
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by…
ICOSAPENT ETHYL
Updated Mar 9 60,541 bottles units
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Drug Recall
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol…
K.C. Pharmaceuticals
Updated Mar 3 74,016 bottles units
Lack of Assurance of Sterility
Drug Recall
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle…
IBUPROFEN
Updated Mar 2 89592 bottles units
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Drug Recall
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty…
SODIUM IODIDE I-131
Updated Feb 19 2,699 blister cartons units
Failed Tablet/Capsule Specifications
Drug Recall
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL…
DEXAMETHASONE SODIUM PHOSPHATE
Updated Feb 4 62190 vials units
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 mont…
Drug Recall
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for…
ISOTRETINOIN
Updated Jan 12 21984 packages units
Superpotent and Subpotent
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Drug Recall
Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL…
Safecor Health
Updated Aug 14 302 syringes units
Cross Contamination with Other Products
Drug Recall
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx…
REVCOVI
Updated Aug 19 3,002 vials units
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Drug Recall
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only…
Apotex
Updated Aug 13 6,972 bottles units
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Drug Recall
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10)…
CARBAMAZEPINE
Updated Aug 7 1200 bottles units
CGMP deviations: tablets with black specks.
Drug Recall
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin…
CLOBETASOL PROPIONATE
Updated Aug 3 5082 tubes units
Failed content uniformity specifications.
Drug Recall
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous…
Apollo Care
Updated Jul 29 9,762 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only…
Apollo Care
Updated Jul 29 4,250 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drug Recall
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous…
Apollo Care
Updated Jul 29 4,748 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by…
DICYCLOMINE HYDROCHLORIDE
Updated Jul 23 6,408 bottles distributed to ma… units
shortfill; reports of empty capsules.
Drug Recall
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only…
Sunny Pharmtech
Updated Jul 17 4,077 vials units
Presence of Particulate Matter; identified as stainless steel
Drug Recall
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only…
Sunny Pharmtech
Updated Jul 17 1,464 vials units
Presence of Particulate Matter; identified as stainless steel
Drug Recall
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only…
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Updated Jul 8 6,192 bottles units
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Drug Recall
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per…
MYCOPHENOLATE MOFETIL
Updated Jul 2 5688 vials units
Presence of precipitate
Drug Recall
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by…
DABIGATRAN ETEXILATE
Updated Jun 30 2,717 cartons units
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity I…
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Drug Recall
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by…
DABIGATRAN ETEXILATE
Updated Jun 30 1,753 cartons units
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity I…
Drug Recall
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine…
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Updated Jun 26 1392 bottles units
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Drug Recall
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb…
AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM
Updated Jun 25 5,762 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34…
CAREONE EARWAX REMOVAL DROPS
Updated Jun 25 1,201 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL…
LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB
Updated Jun 25 5, 471 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For…
Reliance Life Sciences Private
Updated Jun 24 8,001 vials units
Lack of Sterility Assurance
Drug Recall
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous…
Reliance Life Sciences Private
Updated Jun 24 5,020 vials units
Lack of Sterility Assurance
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Drug Recall
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 1,800 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 1,200 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 7,650 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only…
LEVOTHYROXINE SODIUM
Updated Jun 8 6432 bottles units
Subpotent Drug
Drug Recall
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured…
METHOHEXITAL SODIUM
Updated Jun 7 4284 vials units
Failed Impurities/Degradation Specifications
Drug Recall
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One…
SENSIPAR
Updated Jun 4 9565 bottles units
CGMP Deviations
Drug Recall
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for…
Dabur India
Updated Jun 2 5755 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
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Drug Recall
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate…
Dabur India
Updated Jun 2 1225 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for…
Dabur India
Updated Jun 2 4374 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield…
Dabur India
Updated Jun 2 4,738 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz…
Dabur India
Updated Jun 2 1102 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case…
Dabur India
Updated Jun 2 1185 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units…
Dabur India
Updated Jun 2 2503 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units)…
Dabur India
Updated Jun 2 3006 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
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Drug Recall
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield…
Dabur India
Updated Jun 2 4,944 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only…
HYDROXYZINE HYDROCHLORIDE
Updated Jun 2 6564 bottles units
Presence of foreign substance
Drug Recall
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box…
Dabur India
Updated Jun 2 1087 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5…
Dabur India
Updated Jun 2 2420 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg…
Dabur India
Updated Jun 2 8996 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle…
SUN PHARMACEUTICAL INDUSTRIES
Updated Jun 1 9,048 bottles units
Failed Impurities/Degradation Specifications
Drug Recall
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx…
FOCALIN
Updated Jun 1 7,803 bottles units
Labeling: Incorrect or Missing Lot and/or Exp Date
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Drug Recall
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis +…
BEEKEEPER'S NATURALS USA
Updated Jun 1 1680 bottles units
Microbial Contamination of Non-Sterile Products
Drug Recall
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only…
NIACIN
Updated May 29 2,961 bottles units
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 diss…
Drug Recall
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma…
FENOFIBRATE
Updated May 28 3648 bottles units
CGMP Deviations
Drug Recall
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA…
ARIPIPRAZOLE
Updated May 27 6,143 bottles units
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Drug Recall
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed…
NIACIN
Updated May 27 3984 bottles units
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Drug Recall
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC…
PReye
Updated May 18 approximate 50 to 60 bottles units
Lack of Assurance of Sterility
Drug RecallHIGH RISK
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx…
PRED MILD
Updated May 18 2,736 bottles units
Failed Stability Specifications
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Drug Recall
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only…
ESTRADIOL
Updated May 12 3964 Cartons units
Defective Container; packets were found to be either empty or partially full.
Drug Recall
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett…
PRIMIDONE
Updated Apr 27 1,620 bottles units
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Drug Recall
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett…
PRIMIDONE
Updated Apr 27 8,526 bottles units
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Drug Recall
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In…
OCTREOTIDE ACETATE
Updated Apr 24 2,200 kits units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Drug Recall
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed…
NAPROXEN
Updated Apr 20 6,336 bottles units
Chemical contamination; presence of lead and lithium above specification
Drug Recall
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz…
Blaine Labs
Updated Apr 8 1,500 bottles units
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Drug Recall
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6…
TERPENICOL
Updated Apr 8 5,801 bottles units
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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Drug Recall
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6…
TRIDERGEL
Updated Apr 8 519 - 1 oz bottles units
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Drug Recall
Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as…
REVITADERM WOUND CARE
Updated Apr 8 5,555 bottles and tubes units
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Drug Recall
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC…
CLARAVIS
Updated Apr 6 5,101 cartons units
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Drug Recall
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100…
Wells Pharma of Houston
Updated Apr 1 4,030 IV Bags units
cGMP deviations.
Drug Recall
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250…
Wells Pharma of Houston
Updated Apr 1 2940 IV Bags units
cGMP deviations.
Drug Recall
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265…
Wells Pharma of Houston
Updated Apr 1 4975 syringes units
cGMP deviations.
Drug Recall
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading…
FUROSEMIDE
Updated Mar 20 9384 bottles units
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
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Drug Recall
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron…
Fagron Compounding Services
Updated Mar 20 5140 bags units
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Drug Recall
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin…
Island Kinetics d.b.a. CoValence Laboratories
Updated Mar 18 1060 bottles units
Subpotent Drug
Drug Recall
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt…
Island Kinetics d.b.a. CoValence Laboratories
Updated Mar 18 2895 bottles units
Subpotent Drug
Drug Recall
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx…
CUROSURF
Updated Mar 17 7,235 vials units
Lack of Assurance of Sterility
Drug Recall
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg…
OCTREOTIDE ACETATE
Updated Mar 17 1,897 Cartons units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Drug Recall
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE…
Owen Biosciences
Updated Mar 3 7,975 tubes units
Chemical contamination: Presence of benzene
Drug Recall
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml…
Owen Biosciences
Updated Mar 3 9,850 bottles units
Chemical contamination: Presence of benzene
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Drug Recall
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b)…
Owen Biosciences
Updated Mar 3 2,500 bottles units
Chemical contamination: Presence of benzene
Drug Recall
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee…
Owen Biosciences
Updated Mar 3 2269 bottles units
Chemical contamination: Presence of benzene
Drug Recall
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only…
TEMOZOLOMIDE
Updated Mar 3 1200 bottles units
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Drug Recall
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for…
LEVOTHYROXINE SODIUM
Updated Feb 26 1315 bottles units
Subpotent Drug
Drug Recall
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only…
MIDODRINE HYDROCHLORIDE
Updated Feb 17 8892 cartons units
Defective container; inadequately sealed blister packaging.
Drug Recall
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for…
ISOTRETINOIN
Updated Jan 12 8376 packages units
Superpotent and Subpotent
Drug Recall
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper…
ImprimisRx NJ
Updated Aug 24 772 bottles units
Subpotent Drug
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Drug Recall
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation…
Baxter Healthcare
Updated Aug 17 606 bags units
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Drug Recall
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
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Drug Recall
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC…
LEVOTHYROXINE SODIUM
Updated Aug 6 N/A units
Subpotent Drug
Drug Recall
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50…
CLINDAMYCIN PHOSPHATE
Updated Aug 6 N/A units
CGMP Deviations
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Drug Recall
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose…
VANCOMYCIN HYDROCHLORIDE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single…
CLINDAMYCIN PHOSPHATE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL…
VASOPRESSIN IN 0.9% SODIUM CHLORIDE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY…
VANCOMYCIN HYDROCHLORIDE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose…
FAMOTIDINE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL)…
MYXREDLIN
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single…
CLINDAMYCIN PHOSPHATE
Updated Aug 6 N/A units
CGMP Deviations
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Drug Recall
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4…
Baxter Healthcare
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL…
CLINDAMYCIN PHOSPHATE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container…
NEXTERONE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total…
DAPTOMYCIN IN SODIUM CHLORIDE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL)…
PANTOPRAZOLE SODIUM
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200…
CARDENE IV
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg…
DAPTOMYCIN IN SODIUM CHLORIDE
Updated Aug 6 N/A units
CGMP Deviations
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Drug Recall
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL…
VASOPRESSIN IN 0.9% SODIUM CHLORIDE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL…
CLINDAMYCIN PHOSPHATE
Updated Aug 6 N/A units
CGMP Deviations
Drug Recall
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione…
OPTIMAL BALANCE PHARMACY
Updated Aug 5 53 vials units
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Drug Recall
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by…
MIRABEGRON
Updated Aug 5
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Drug Recall
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing…
DIOVAN
Updated Aug 4
Failed Dissolution Specifications
Drug Recall
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL…
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Updated Jul 30
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Drug Recall
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only…
Apollo Care
Updated Jul 29 250 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drug Recall
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only…
Apollo Care
Updated Jul 29 500 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx…
Apollo Care
Updated Jul 29 250 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx…
Apollo Care
Updated Jul 29 250 vials. units
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drug Recall
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan…
ACAMPROSATE CALCIUM
Updated Jul 24
Failed Dissolution Specifications
Drug Recall
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by…
AZELAIC ACID
Updated Jul 23 N/A units
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were receive…
Drug Recall
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx…
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
Updated Jul 22 N/A units
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Drug Recall
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific)…
Central Admixture Pharmacy Services
Updated Jul 16 (2) patient-specific TPN prescr… units
Incorrect Product Formulation
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Drug Recall
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single…
LIDOLOG KIT
Updated Jul 15 18 kits units
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Drug Recall
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose…
GLYCOPYRROLATE
Updated Jul 14 N/A units
Failed Impurities/Degradation Specifications
Drug Recall
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN…
Rohto-Mentholatum (Vietnam)
Updated Jul 14 353 cartons units
Lack of Assurance of Sterility
Drug Recall
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
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Drug Recall
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
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Drug Recall
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose…
LEVOTHYROXINE SODIUM
Updated Jul 13 N/A units
Subpotent Drug
Drug Recall
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic…
Victory Medical Center Pharmacy
Updated Jul 1 91 units
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Drug Recall
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla…
CINACALCET
Updated Jun 29 N/A units
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Drug Recall
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla…
CINACALCET
Updated Jun 29 N/A units
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Drug Recall
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only…
DIVALPROEX SODIUM
Updated Jun 26 N/A units
Presence of Foreign Tablets/Capsules
Drug Recall
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC…
MEIJER EARWAX REMOVAL KIT
Updated Jun 25 993 units units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug Recall
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded…
QuVa Pharma
Updated Jun 24 N/A units
Failed Impurities/Degradation Specifications
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Drug Recall
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60…
Direct Rx
Updated Jun 22 263 Bottles units
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Drug Recall
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10)…
METHYLERGONOVINE MALEATE
Updated Jun 16 790 Cartons. units
Subpotent Drug
Drug Recall
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)…
Boehringer Ingelheim Pharmaceuticals
Updated Jun 12 560 bottles units
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previousl…
Drug Recall
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol…
PURPREP
Updated Jun 11 N/A units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 125 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol)…
CHLORAPREP ONE-STEP
Updated Jun 11 100 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Drug Recall
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated Jun 11 400 units units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
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Drug Recall
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For…
GEMCITABINE
Updated Jun 10 74 units units
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Drug Recall
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial…
IMULDOSA
Updated Jun 10 326 vials units
Lack of assurance of Sterility:
Drug Recall
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed…
LIDOCAINE HYDROCHLORIDE
Updated Jun 8 N/A units
Lack of Assurance of Sterility
Drug Recall
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose…
ACCUCAINE
Updated Jun 8 N/A units
Lack of Assurance of Sterility
Drug Recall
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One…
SENSIPAR
Updated Jun 4 N/A units
CGMP Deviations
Drug Recall
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand…
CORLANOR
Updated Jun 4 N/A units
Presence of Foreign Substance.
Drug Recall
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One…
SENSIPAR
Updated Jun 4 N/A units
CGMP Deviations
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Drug Recall
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx#…
Central Admixture Pharmacy Services
Updated Jun 2 One (1) patient-specific TPN pr… units
Incorrect product formulation: bag did not contain copper and famotidine per label.
Drug Recall
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin…
Dabur India
Updated Jun 2 84 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel…
Dabur India
Updated Jun 2 84 tubes units
CGMP Deviations; deficiencies observed during FDA inspection
Drug Recall
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by…
Gas Industrial
Updated May 29 N/A units
Subpotent drug
Drug Recall
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed…
Gas Industrial
Updated May 29 N/A units
Subpotent drug
Drug Recall
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco…
Gas Industrial
Updated May 29 N/A units
Subpotent drug
Drug Recall
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by…
Gas Industrial
Updated May 29 N/A units
Subpotent drug
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Drug Recall
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo…
Gas Industrial
Updated May 29 N/A units
Subpotent drug
Drug Recall
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco…
Gas Industrial
Updated May 29 N/A units
Subpotent drug
Drug Recall
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5…
BUDESONIDE
Updated May 29 N/A units
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and …
Drug Recall
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol…
CHLORAPREP ONE-STEP
Updated May 28 N/A units
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Drug Recall
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
CHLORAPREP ONE-STEP
Updated May 28 N/A units
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Drug Recall
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable…
ULTRA STRENGTH ANTACID ASSORTED FRUIT
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
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Drug Recall
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets…
EQUALINE EXTRA STRENGTH ASSORTED BERRY ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets…
GOODSEN EXTRA STRENGTH ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets…
EQU ULTRA STRENGTH ANTACID ASSORTED FRUIT 171AF
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets…
ULTRA STRENGTH ANTACID ASSORTED BERRIES
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable…
GOODSEN ULTRA STRENGTH ANTACID ASSORTED FRUIT
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
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Drug Recall
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE…
TOPCARE ULTRA STRENGTH ANTACID ASSORTED FRUIT
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets…
EXTRA STRENGTH ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle…
KIRKLAND ULTRA STREGTH ANTACID 171AB
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
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Drug Recall
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable…
GOOD NEIGHBOR PHARMACY ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96…
HEB EXTRA STREGTH ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed…
Guardian Drug
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE…
FAMILY WELLNESS ULTRA STRENGTH ASSORTED FRUIT ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
Drug Recall
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE…
TOPCARE EXTRA STRENGTH ANTACID
Updated May 28
Presence of foreign substance: small metallic particles in chewable tablets.
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Drug Recall
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg…
ALYACEN 1/35
Updated May 27
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Drug Recall
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in…
ZEP ALCOHOL SANITIZER
Updated May 22 5 drums units
Microbial contamination of sterile products
Drug Recall
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma…
SUN PHARMACEUTICAL INDUSTRIES
Updated May 22
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the prop…
Drug Recall
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma…
SUN PHARMACEUTICAL INDUSTRIES
Updated May 22
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the prop…
Drug Recall
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz…
SAF SENSICAINE ULTRA TOPICAL ANESTHETIC GEL
Updated May 21 150 units units
Defective container:may contain bottles with incomplete seals
Drug Recall
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g)…
DENTAL CITY TOPICAL ANESTHETIC
Updated May 21 450 units units
Defective container:may contain bottles with incomplete seals
Drug Recall
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL)…
BURKHART TOPICAL ANESTHETIC
Updated May 21 150 units units
Defective container:may contain bottles with incomplete seals
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Drug Recall
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net…
QUALA TOPICAL ANESTHETIC GEL
Updated May 21 150 units units
Defective container:may contain bottles with incomplete seals
Drug Recall
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor…
PURELIFE TOPICAL ANESTHETIC
Updated May 21 450 units units
Defective container:may contain bottles with incomplete seals
Drug Recall
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured…
HEALTH-TEC TOPICAL ANESTHETIC
Updated May 21 150 units units
Defective container:may contain bottles with incomplete seals
Drug Recall
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz…
PEARSON TOPICAL ANESTHETIC
Updated May 21 900 units units
Defective container:may contain bottles with incomplete seals
Drug Recall
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1…
Shimoga Chemicals
Updated May 19 N/A units
cGMP deviations
Drug Recall
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding…
IntegraDo Compounding Services
Updated May 18 287 units units
Subpotent Drug
Drug Recall
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated…
PAI Holdings
Updated May 15
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
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Drug Recall
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated…
PAI Holdings
Updated May 15
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Drug Recall
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated…
PAI Holdings
Updated May 15
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Drug Recall
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated…
PAI Holdings
Updated May 15
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Drug Recall
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem…
DULOXETINE
Updated May 14 50 bottles units
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake lim…
Drug Recall
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose…
DOXORUBICIN HYDROCHLORIDE
Updated May 12 675 vials units
Presence of Particulate matter: Particulate matter identified as glass.
Drug Recall
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water…
IntegraDo Compounding Services
Updated May 12 376 cassettes units
Subpotent Drug
Drug Recall
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic…
Safecor Health
Updated May 1 520 syringes units
Presence of a Foreign Substance; black particles observed in liquid
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Drug Recall
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in…
ATOMOXETINE
Updated Apr 30 149 capsules units
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Drug Recall
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile…
OASIS TEARS PF
Updated Apr 27
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a rece…
Drug Recall
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz…
Wisconsin Pharmacal
Updated Apr 24 690 tubes units
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Drug Recall
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by…
ENALAPRIL MALEATE
Updated Apr 23 675 bottles units
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Drug Recall
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France…
IVIZIA DRY EYE
Updated Apr 23
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufact…
Drug Recall
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made…
Thea Pharma
Updated Apr 23
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufact…
Drug Recall
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol…
PURPREP
Updated Apr 22
Lack of assurance of Sterility: potential product contamination
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Drug Recall
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol…
PURPREP
Updated Apr 22
Lack of assurance of Sterility: potential product contamination
Drug Recall
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for…
SYSTANE
Updated Apr 21
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Drug Recall
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon…
GENTEAL TEARS
Updated Apr 21
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Drug Recall
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile…
OPTA
Updated Apr 20
Lack of Assurance of Sterility
Drug Recall
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer…
MONSELS SOLUTION
Updated Apr 14 573 cartons units
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct …
Drug Recall
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle…
TRIPENICOL S
Updated Apr 8 144 bottles units
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Drug Recall
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by…
DESMOPRESSIN ACETATE
Updated Apr 8 N/A units
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
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Drug Recall
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose…
ALENDRONATE SODIUM
Updated Apr 7 4 single dose 75 ml bottles units
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Drug Recall
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only…
LIDOCAINE HYDROCHLORIDE
Updated Apr 2 N/A units
Lack of Assurance of Sterility
Drug Recall
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL)…
Wells Pharma of Houston
Updated Apr 1 50 syringes units
cGMP deviations.
Drug Recall
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25…
Wells Pharma of Houston
Updated Apr 1 50 syringes units
cGMP deviations.
Drug Recall
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per…
Wells Pharma of Houston
Updated Apr 1 150 syringes units
cGMP deviations.
Drug Recall
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical…
Avantor Performance Materials
Updated Mar 31 36 bottles units
Subpotent drug
Drug Recall
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene…
ARTIFICIAL TEARS
Updated Mar 25 720 bottles units
Lack of Assurance of Sterility
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Drug Recall
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister…
MEMANTINE HYDROCHLORIDE
Updated Mar 24 N/A units
Failed Dissolution Specifications
Drug RecallHIGH RISK
Kian Pee Wan Capsules, 30-count bottles
Buy-Herbal
Updated Mar 21 71 bottles units
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Drug Recall
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough…
HONEY LEMON FLAVOR COUGH DROP
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic…
DISCOUNT DRUG MART
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey…
MGC HEALTH
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon…
MGC HEALTH
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry…
QUALITY CHOICE
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
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Drug Recall
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon…
MGC HEALTH
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol…
QUALITY CHOICE
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count…
CARING MILL COUGH DROPS CHERRY
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey…
QUALITY CHOICE COUGH DROPS VANILLA HONEY
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor…
MENTHOL FLAVOR COUGH DROP
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry…
QUALITY CHOICE COUGH DROPS CREAMY STRAWBERRY
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free…
QUALITY CHOICE
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
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Drug Recall
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon…
QUALITY CHOICE
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey…
DISCOUNT DRUG MART
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free…
QUALITY CHOICE
Updated Mar 20 N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Drug Recall
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar…
Island Kinetics d.b.a. CoValence Laboratories
Updated Mar 18 299 bottles units
Subpotent Drug
Drug Recall
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only…
XANAX
Updated Mar 17
Failed Dissolution Specifications
Drug Recall
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65)…
MECLIZINE HYDROCHLORIDE
Updated Mar 16 697 cartons units
Failed tablet specifications.
Drug Recall
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only…
LANREOTIDE ACETATE
Updated Mar 13
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection pr…
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Drug Recall
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag…
DEXTRO
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex…
DEXTRO
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag…
DEXTRO
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
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Drug Recall
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
Drug Recall
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton…
SODIUM CHLORIDE
Updated Mar 11
Lack of Assurance of Sterility
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Drug Recall
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx…
PAYLESS COMPOUNDERS
Updated Mar 6 91 vials units
Lack of Assurance of Sterility
Drug Recall
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley…
New Life Pharma
Updated Feb 26 2 vials units
Lack of Assurance of Sterility
Drug Recall
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC…
Harbin Jixianglong Biotech
Updated Feb 13 N/A units
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation befo…
Drug Recall
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for…
PITAVASTATIN CALCIUM
Updated Feb 3 770 bottles units
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Drug Recall
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%)…
ACME UNITED
Updated Jan 20 N/A units
CGMP Deviations
Drug Recall
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme…
FIRST AID ONLY BZK ANTISEPTIC
Updated Jan 20 N/A units
CGMP Deviations
Drug Recall
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7…
BZK PADS
Updated Jan 20 N/A units
CGMP Deviations
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Drug Recall
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes…
MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC
Updated Jan 20 N/A units
CGMP Deviations
Drug Recall
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only…
Central Admixture Pharmacy Services (CAPS) Los Angeles
Updated Dec 27 1 bag units
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Data sources: openFDA · CPSC · Last updated: 2026-09-23 07:30:11 ET

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