FDAFDA · Food and drugs·Recall number D-0171-2025
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
Published January 8, 2025 · Recall initiated: December 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DAPSONE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Distributor
- US Nationwide
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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