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109 recalls match
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.
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
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.
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
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, 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.
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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
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
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
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
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
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…
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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 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
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
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
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
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
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
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
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 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
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
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 …
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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
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
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.
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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
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
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.
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
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
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
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.
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
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
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…
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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
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
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
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.
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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
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
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 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 …
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 …
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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 …
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 …
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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
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
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic…
BROMFENAC SODIUM
Updated Mar 18
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
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
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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…
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
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
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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
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
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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
0.45% 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
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
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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
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
Data sources: openFDA · CPSC · Last updated: 2026-05-06 07:30:08 ET

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