Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
Apr 4, 2022 Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals... 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 T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as... 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-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . A... 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 Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Mul... 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-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 1... 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 SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Mult... 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 NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml... 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 T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, ... 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 4, 2022 PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... 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 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 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 Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi... 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 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 Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL... 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,... Failed Reconstitution time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Steril... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Hand Sanitizer LLC
Apr 4, 2022 RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Mu... 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 PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmac... 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 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 T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg... 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 BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Ha... CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. Class II Beak & Skiff Cider Mill, Inc.
Apr 4, 2022 RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Pa... 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 Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL... 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 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 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...
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 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 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 Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... Subpotent Class III Jubilant Cadista 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, 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 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 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 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 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 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 30, 2022 Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chloro... Chemical contamination: presence of benzene Class I Unilever United States 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 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 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 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 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.

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.