Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Mar 23, 2023 Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Acco... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accor... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufacture... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (ND... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Acc... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accor... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactu... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 22, 2023 Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distribute... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed ... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 20, 2023 Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged ... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) ... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-0... cGMP Deviations Class II RemedyRepack Inc.
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

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.