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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.