VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pha…

Recall date

December 10, 2024

Source

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

Recall number

D-0171-2025

FDA classification

Class II

Brand / firm

VIONA PHARMACEUTICALS INC

Sold / distributed

US Nationwide

Why it was recalled

Crystallization

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

What was recalled

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack