Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
Mar 20, 2023 Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepac... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03)... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-0... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01... cGMP Deviations Class II RemedyRepack Inc.
Mar 17, 2023 Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 6800... CGMP Deviations: recalling drug products following an FDA inspection. Class II Amerisource Health Services LLC
Mar 17, 2023 Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 6... CGMP Deviations: recalling drug products following an FDA inspection. Class II Amerisource Health Services LLC
Mar 17, 2023 Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 680... CGMP Deviations: recalling drug products following an FDA inspection. Class II Amerisource Health Services LLC
Mar 16, 2023 Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackag... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repac... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-8... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 14, 2023 Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx ... CGMP Deviations: Discoloration Class II Hetero USA Inc
Mar 14, 2023 Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufa... CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... Class II Ascend Laboratories, LLC
Mar 14, 2023 Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,... CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... Class II Ascend Laboratories, LLC
Mar 13, 2023 Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II Direct Rx
Mar 13, 2023 Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-c... cGMP deviations Class II Direct Rx
Mar 13, 2023 Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... cGMP deviations Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II Direct Rx
Mar 13, 2023 Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72... cGMP deviations Class II Direct Rx
Mar 13, 2023 Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II Direct Rx
Mar 13, 2023 Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II Direct Rx
Mar 13, 2023 Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC... cGMP deviations Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-04... cGMP deviations Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... cGMP deviations Class II Direct Rx
Mar 13, 2023 Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II Direct Rx
Mar 2, 2023 Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... CGMP Deviations: Potential risk of Cross Contamination Class II Breckenridge Pharmaceutical, Inc
Mar 2, 2023 Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... CGMP Deviations: Potential risk of Cross Contamination Class II Breckenridge Pharmaceutical, Inc
Mar 2, 2023 Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... CGMP Deviations: Potential risk of Cross Contamination Class II Breckenridge Pharmaceutical, Inc
Mar 2, 2023 Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... CGMP Deviations: Potential risk of Cross Contamination Class II Breckenridge Pharmaceutical, Inc
Mar 2, 2023 Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... CGMP Deviations: Potential risk of Cross Contamination Class II Breckenridge Pharmaceutical, Inc
Mar 2, 2023 Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... CGMP Deviations: Potential risk of Cross Contamination Class II Breckenridge Pharmaceutical, Inc
Feb 24, 2023 Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid o... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (20... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 23, 2023 NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid D... CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class II Nutraceutical Corporation
Feb 23, 2023 NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), ... CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class II Nutraceutical Corporation
Feb 23, 2023 NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, ... CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class II Nutraceutical Corporation
Feb 23, 2023 NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% A... CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class II Nutraceutical Corporation
Feb 23, 2023 Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... CGMP Deviations: Potential product carryover. Class II Nephron Sc Inc
Feb 22, 2023 Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... Class II Teva Pharmaceuticals USA Inc
Feb 21, 2023 Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health

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.