VIONA PHARMACEUTICALS INC recalls Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad,…

Recall date

October 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0016-2026

FDA classification

Class II

Brand / firm

VIONA PHARMACEUTICALS INC

Sold / distributed

USA Nationwide

Why it was recalled

Discoloration

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.