Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 5, 2022 | Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonv... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Direct Rx |
| May 4, 2022 | Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repac... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | RemedyRepack Inc. |
| May 3, 2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Preferred Pharmaceuticals, Inc. |
| May 3, 2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5,... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Preferred Pharmaceuticals, Inc. |
| May 2, 2022 | Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| May 2, 2022 | Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged ND... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| Apr 25, 2022 | Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manu... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manuf... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 21, 2022 | Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, H... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Torco Race Fuels |
| Apr 21, 2022 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 15, 2022 | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... | cGMP Deviations | Class II | Teva Pharmaceuticals USA Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 13, 2022 | Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalatio... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial,... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG:... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bot... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Ph... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), package... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dos... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-352... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured b... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose t... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: San... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
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.