Recalls / Class II
Class IID-0172-2025
Product
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
- Brand name
- Dapsone
- Generic name
- Dapsone
- Active ingredient
- Dapsone
- Route
- Topical
- NDC
- 72578-094
- FDA application
- ANDA214019
- Affected lot / code info
- Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
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, Cranford, New Jersey 07016-3617
Distribution
- Quantity
- 2760 packs
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2024-12-10
- FDA classified
- 2025-01-02
- Posted by FDA
- 2025-01-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0172-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.