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
See What To Do ↓
Hazard. Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
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…
See What To Do ↓
Hazard. Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
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
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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…
See What To Do ↓
Hazard. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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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.
See What To Do ↓
Hazard. cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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."
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Presence of particulate matter
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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
See What To Do ↓
Hazard. CGMP Deviations: use of an unapproved raw material
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
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. 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 instead.
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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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.
See What To Do ↓
Hazard. Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
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.
See What To Do ↓
Hazard. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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…
See What To Do ↓
Hazard. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
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
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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.
See What To Do ↓
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
See What To Do ↓
Hazard. Failed Stability Specifications
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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Presence of foreign substance: small metallic particles in chewable tablets.
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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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Presence of foreign substance: small metallic particles in chewable tablets.
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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Presence of foreign substance: small metallic particles in chewable tablets.
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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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Presence of foreign substance: small metallic particles in chewable tablets.
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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Presence of foreign substance: small metallic particles in chewable tablets.
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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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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
See What To Do ↓
Hazard. 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 …
See What To Do ↓
Hazard. Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
Presence of particulate matter: identified as Buprenorphine free base
See What To Do ↓
Hazard. Presence of particulate matter: identified as Buprenorphine free base
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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
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
See What To Do ↓
Hazard. Superpotent and Subpotent
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
See What To Do ↓
Hazard. Failed Stability Specifications
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.
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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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.
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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
See What To Do ↓
Hazard. Chemical contamination; presence of lead and lithium above specification
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
See What To Do ↓
Hazard. 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.
See What To Do ↓
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.
See What To Do ↓
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.
See What To Do ↓
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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.
See What To Do ↓
Hazard. CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
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
See What To Do ↓
Hazard. 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
See What To Do ↓
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
See What To Do ↓
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
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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
See What To Do ↓
Hazard. Chemical contamination: Presence of benzene
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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
See What To Do ↓
Hazard. Chemical contamination: Presence of benzene
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Superpotent and Subpotent
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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…
See What To Do ↓
Hazard. Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
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…
See What To Do ↓
Hazard. CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
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
See What To Do ↓
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
See What To Do ↓
Hazard. Presence of a Foreign Substance; black particles observed in liquid
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.
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
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.
See What To Do ↓
Hazard. Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
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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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
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
See What To Do ↓
Hazard. Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
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
See What To Do ↓
Hazard. Lack of assurance of Sterility: potential product contamination
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
See What To Do ↓
Hazard. 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.
See What To Do ↓
Hazard. 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.
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Hazard. Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
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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
See What To Do ↓
Hazard. 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 …
See What To Do ↓
Hazard. 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 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
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.
See What To Do ↓
Hazard. Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
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.
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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.
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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.
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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.
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Drug Recall
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical…
Avantor Performance Materials
Updated Mar 31 36 bottles units
Subpotent drug
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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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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
See What To Do ↓
Hazard. Failed Dissolution Specifications
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
See What To Do ↓
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
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Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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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 …
See What To Do ↓
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
See What To Do ↓
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
See What To Do ↓
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
See What To Do ↓
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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 …
See What To Do ↓
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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
See What To Do ↓
Drug Recall
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only…
XANAX
Updated Mar 17
Failed Dissolution Specifications
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Hazard. Failed Dissolution Specifications
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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.
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. Lack of Assurance of Sterility
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
See What To Do ↓
Hazard. 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
See What To Do ↓
Hazard. 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…
See What To Do ↓
Hazard. CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
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
See What To Do ↓
Hazard. 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
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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
See What To Do ↓
Drug Recall
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7…
BZK PADS
Updated Jan 20 N/A units
CGMP Deviations
See What To Do ↓
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
See What To Do ↓
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.
See What To Do ↓
Hazard. Incorrect Product Formulation: product did not contain insulin as listed in the label.
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