Dapsone Gel 7 — Class II drug recall D-0038-2025
Ongoing recall by VIONA PHARMACEUTICALS INC, reported 2024-11-13, distributed nationwide. Crystallization
| Recall number | D-0038-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | VIONA PHARMACEUTICALS INC, Cranford, NJ, United States |
| Recall initiated | 2024-10-29 |
| Classified | 2024-11-05 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 6,048 pumps |
| NDC | 72578-0094, 72578-0094-01, 72578-0094-02, 72578-0094-03 |
| Lot numbers | T400806, T401151 |
| Expiration dates | 2026-03-31, 2026-06-30 |
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.
Reason for recall
Crystallization
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0038-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.