Tavaborole Recall: Viona Pharmaceuticals Lot T400819/T400820
Announced 2025-10-22 · FDA
The recall involves Tavaborole Topical Solution 5%, 10 mL Rx bottles distributed nationwide in the USA by Viona Pharmaceuticals Inc. due to discoloration. About 13,080 bottles are affected across three lots: Lot T400819 and T400820 (Exp 4/30/26) and Lot T401969 (Exp 9/30/26). No corrective action is listed.
| Brand | VIONA PHARMACEUTICALS INC |
|---|---|
| Product | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. |
| Reason | Discoloration |
| Severity | moderate |
| Units affected | 13080 |
| Distribution | USA Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26 |
WHAT YOU SHOULD DO
- Stop using the recalled product if you have a bottle that matches the affected lots.
- Discontinue use and follow local guidance to return or dispose of the product.
- Contact Viona Pharmaceuticals or your healthcare provider with the lot numbers for guidance on replacement or refunds.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.