Azelaic Acid Gel — Class II drug recall D-0731-2026
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2026-08-05, distributed nationwide. CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, g
| Recall number | D-0731-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ, United States |
| Recall initiated | 2026-07-23 |
| Classified | 2026-07-28 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 68462-0626, 68462-0626-52 |
| Lot numbers | 19260937A, 19261185A, 19261225A, 19261664A, 19261682A |
| Expiration dates | 2028-02-20, 2028-03-20, 2028-04-20 |
Product
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Reason for recall
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
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-0731-2026. 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.