FDA Drugs recall ·
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd… recall
- Recall number
- D-0171-2025
- Date
- (initiated December 10, 2024)
- Company / brand
- Viona Pharmaceuticals Inc
20 Commerce Dr Ste 340, Cranford, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23304 packs
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Crystallization
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
Distribution
US Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0171-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.