Browse Drug Recalls
9 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 9 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 9 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 8, 2026 | TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Ma... | CGMP Deviations; the firm discontinued required stability testing for products on the market stil... | Class II | Blaine Labs Inc |
| Apr 8, 2026 | TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 ... | CGMP Deviations: product manufactured in the same facility under the same conditions as the produ... | Class II | Blaine Labs Inc |
| Apr 8, 2026 | vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manuf... | CGMP Deviations; the firm discontinued required stability testing for products on the market stil... | Class II | Blaine Labs Inc |
| Apr 8, 2026 | Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) ... | CGMP Deviations; product manufactured in the same facility under the same conditions as the produ... | Class II | Blaine Labs Inc |
| Apr 8, 2026 | TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL)... | CGMP Deviations; the firm discontinued required stability testing for products on the market stil... | Class II | Blaine Labs Inc |
| Apr 8, 2026 | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ ... | Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus... | Class I | Blaine Labs Inc |
| Apr 8, 2026 | Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains,... | CGMP Deviations; the firm discontinued required stability testing for products on the market stil... | Class II | Blaine Labs Inc |
| Apr 8, 2026 | TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 F... | CGMP Deviations; the firm discontinued required stability testing for products on the market stil... | Class II | Blaine Labs Inc |
| Jan 25, 2022 | REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transfo... | Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated... | Class I | Blaine Labs 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.