US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Sep 24, 2024 (2 years ago)

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd…

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

Why it was recalled

Crystallization

What was recalled

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

Recalling firm
Viona Pharmaceuticals INC
NDC code
72578-094-02
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0011-2025

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.

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