US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Aug 12, 2025 (13 months ago)

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Discoloration

What was recalled

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

Recalling firm
Viona Pharmaceuticals INC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0595-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.