Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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DateProductReasonClassFirm
Mar 31, 2023 Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 29, 2023 Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... Sub-potent drug: assay test result below specifications at 9-month timepoint. Class III Accord Healthcare, Inc.
Mar 29, 2023 Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 27, 2023 Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. Class III Teva Pharmaceuticals USA Inc
Mar 27, 2023 Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-steril... CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of met... Class II Jarman's Midwest Cleaning Systems, Inc.
Mar 27, 2023 SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STER... Chemical Contamination: FDA testing found Presence of methanol Class I Jarman's Midwest Cleaning Systems, Inc.
Mar 27, 2023 Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. Class III Pine Pharmaceuticals, LLC
Mar 27, 2023 Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solutio... Chemical Contamination: FDA testing found Presence of methanol Class I Jarman's Midwest Cleaning Systems, 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 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 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 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 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 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 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 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 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 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 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, 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 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 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 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 Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
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 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, 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 20, 2023 Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01... 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 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01... 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 Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03)... 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 Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-0... 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 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 Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... 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 Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged ... cGMP Deviations Class II RemedyRepack Inc.
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 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 Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manuf... Out of specification (OOS) for Spectroscopic Identification test by IR. Class II Ascend Laboratories, LLC

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.