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 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 16, 2023 Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/m... Labeling; Incorrect NDC number on outer carton of product. Class III Focus Health Group Inc
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 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 Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-... 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 Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (1... Failed Dissolution Specifications: Out of specification dissolution results above specified values. Class II Amerisource Health Services 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 Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 15, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Amb... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Mar 15, 2023 Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
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 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 Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx ... CGMP Deviations: Discoloration Class II Hetero USA Inc
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 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 Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-04... 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 Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... 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 Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72... cGMP deviations Class II Direct Rx
Mar 13, 2023 Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... Class I Camber Pharmaceuticals Inc.
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 Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... 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 Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II Direct Rx
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx ... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx ... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 9, 2023 JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01... Labeling: Label Mix-up Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 9, 2023 Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... Failed Content Uniformity Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 8, 2023 MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry... Class III Pfizer Inc.
Mar 2, 2023 Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL correspon... Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification result... Class II Endo Pharmaceuticals, 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
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, 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, 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 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 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 1, 2023 Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dext... Subpotent Drug: low Anti-Factor IIa potency. Class II B. Braun Medical Inc
Mar 1, 2023 Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartr... Class II Apotex Corp.
Feb 28, 2023 Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose ... Labeling: Not elsewhere classified Class II Sagent Pharmaceuticals Inc
Feb 24, 2023 Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... 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 Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... Class III Zydus Pharmaceuticals (USA) 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 Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... 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.

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.