Recalls / Class II
Class IID-0038-2025
Product
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.
- Brand name
- Dapsone
- Generic name
- Dapsone
- Active ingredient
- Dapsone
- Route
- Topical
- NDC
- 72578-094
- FDA application
- ANDA214019
- Affected lot / code info
- Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
Why it was recalled
Crystallization
Recalling firm
- Firm
- VIONA PHARMACEUTICALS INC
- Manufacturer
- Viona Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Commerce Dr Ste 340, N/A, Cranford, New Jersey 07016-3617
Distribution
- Quantity
- 6048 pumps
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-10-29
- FDA classified
- 2024-11-05
- Posted by FDA
- 2024-11-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0038-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.