VIONA PHARMACEUTICALS INC recalls Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifescien…

Recall date

August 12, 2025

Source

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

Recall number

D-0595-2025

FDA classification

Class II

Brand / firm

VIONA PHARMACEUTICALS INC

Sold / distributed

Nationwide in the USA

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 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