Browse Drug Recalls
8 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 8 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 8 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 6, 2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus... | Discoloration | Class II | VIONA PHARMACEUTICALS INC |
| Aug 12, 2025 | Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical ... | Discoloration | Class II | VIONA PHARMACEUTICALS INC |
| Dec 10, 2024 | Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... | Crystallization | Class II | VIONA PHARMACEUTICALS INC |
| Dec 10, 2024 | Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... | Crystallization | Class II | VIONA PHARMACEUTICALS INC |
| Oct 29, 2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences ... | Crystallization | Class II | VIONA PHARMACEUTICALS INC |
| Sep 24, 2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences ... | Crystallization | Class II | VIONA PHARMACEUTICALS INC |
| Dec 27, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ... | CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS INC |
| Jun 1, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS 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.