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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.