US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Oct 6, 2025 (11 months ago)

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus…

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 bottle, Rx 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
NDC code
72578-102-04
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0016-2026

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.