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

FDA recall notice · announced August 27, 2025 · Viona Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: T401968
Quantity: 3960 bottles
Status: Ongoing
Products in this recall event:
- 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., (D-0595-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.