FDA Drug recall D-0038-2025
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals…
- FDA Drug
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals… by Viona Pharmaceuticals, citing crystallization.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0038-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-29 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viona Pharmaceuticals |
| Distribution | US |
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
Crystallization
Identifiers
| ndc | 72578-094-01 |
|---|---|
| ndc | 72578-094-02 |
| ndc | 72578-094-03 |
| code_info | Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0038-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.