Why it was recalled
Crystallization
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0171-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 10, 2024
- FDA report date
- Jan 8, 2025
- Quantity
- 23304 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIONA PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0171-2025, exactly as published.
Show all FDA fields
- City
- Cranford
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95930
- Address
- 20 Commerce Dr Ste 340
- Code information
- 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.
- Postal code
- 07016-3617
- Report date
- Jan 8, 2025
- Product type
- Drugs
- Recall number
- D-0171-2025
- Classification
- Class II
- Recalling firm
- VIONA PHARMACEUTICALS INC
- Product quantity
- 23304 packs
- Reason for recall
- Crystallization
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Dec 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2025