Tavaborole Topical Solution 5% — Class II drug recall D-0595-2025
Ongoing recall by VIONA PHARMACEUTICALS INC, reported 2025-08-27, distributed nationwide. Discoloration
| Recall number | D-0595-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | VIONA PHARMACEUTICALS INC, Cranford, NJ, United States |
| Recall initiated | 2025-08-12 |
| Classified | 2025-08-21 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 3,960 bottles |
| NDC | 72578-0102, 72578-0102-04 |
| Lot numbers | T401968 |
Product
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
Reason for recall
Discoloration
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0595-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.