Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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Date	Product	Reason	Class	Firm
Apr 4, 2022	SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/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 4, 2022	Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, ...	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-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dos...	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	ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10...	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	BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, R...	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	Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ...	Subpotent	Class III	Jubilant Cadista Pharmaceuticals, Inc.
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 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	23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille...	Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro...	Class III	The Ritedose Corporation
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	Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si...	Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ...	Class III	SUN PHARMACEUTICAL INDUSTRIES 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, 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 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 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	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 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 30, 2022	Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chloro...	Chemical contamination: presence of benzene	Class I	Unilever United States 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 29, 2022	Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manu...	Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde...	Class I	Pink Toyz
Mar 29, 2022	Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, ...	Incorrect/Undeclared Excipient: Product contains alcohol	Class III	AptaPharma Inc.
Mar 29, 2022	IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, ...	Presence of Particulate Matter: Product was found to contain silica and iron oxide	Class I	Teva Pharmaceuticals USA Inc
Mar 29, 2022	Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best B...	Chemical Contamination; FDA analysis found product to contain methanol	Class I	Best Brands Consumer Products, Inc.
Mar 29, 2022	The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Be...	Chemical Contamination; FDA analysis found product to contain benzene	Class I	Best Brands Consumer Products, 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	Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ...	Microbial Contamination of Non-Sterile Products	Class I	Plastikon Healthcare LLC
Mar 24, 2022	MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag...	Microbial Contamination of Non-Sterile Products	Class I	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	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	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	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 (10ML) 200MG/0.5MG/ML; Packaged ...	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/ 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	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	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 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	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 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	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/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 21, 2022	SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled...	Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr...	Class I	Adamis Pharmaceuticals Corporation
Mar 21, 2022	SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled ...	Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr...	Class I	Adamis Pharmaceuticals Corporation
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	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.

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.