Browse Drug Recalls
13 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 13 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 13 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength ... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | 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 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 |
| Jul 18, 2018 | Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pha... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Ph... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: No... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Nov 10, 2015 | Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... | Labeling: Not elsewhere classified. NDC number is incorrect on the container. | Class III | Northwind Pharmaceuticals 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.