Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Apr 4, 2022 Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharma... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atro... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropi... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 1, 2022 CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered... Marketed Without an Approved NDA/ANDA Class II Wellness BioSciences
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Apr 1, 2022 Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufact... Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results... Class II Mylan Pharmaceuticals Inc
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 31, 2022 Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Lupin Pharmaceuticals Inc.
Mar 31, 2022 Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Lupin Pharmaceuticals Inc.
Mar 31, 2022 Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottl... Presence of foreign substance: Presence of stainless steel particulates in tablets. Class II MERCK SHARP & DOHME CORP
Mar 31, 2022 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-c... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Lupin Pharmaceuticals Inc.
Mar 31, 2022 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Lupin Pharmaceuticals Inc.
Mar 31, 2022 Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Lupin Pharmaceuticals Inc.
Mar 31, 2022 Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Lupin Pharmaceuticals Inc.
Mar 30, 2022 Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chloroh... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II Unilever United States Inc.
Mar 28, 2022 Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delay... Out of specification results observed in dissolution during long term stability testing. Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per ... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Pre... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2022 Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bot... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2022 TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Package... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... Failed Dissolution Specifications; during long term stability testing. Class II Dr. Reddy's Laboratories, Inc.
Mar 23, 2022 TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dos... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx O... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2022 TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... Failed Dissolution Specifications; during long term stability testing. Class II Dr. Reddy's Laboratories, Inc.
Mar 23, 2022 TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable,... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, F... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tab... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (5... Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Pep... Class II Revive Personal Products Company
Mar 21, 2022 quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, ... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tab... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Table... CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Class II Sandoz, Inc
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only,... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablet... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tabl... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablet... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 17, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by:... Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which ... Class II Aurolife Pharma, LLC
Mar 16, 2022 Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufact... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 16, 2022 Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactu... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 16, 2022 Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufac... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 16, 2022 Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufact... CGMP Deviations Class II Golden State Medical Supply Inc.
Mar 15, 2022 Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams t... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.