Azelaic Acid Gel — Class II drug recall D-0662-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-10-01, distributed nationwide. CGMP Deviations: Market complaints received for gritty texture (grainy)
| Recall number | D-0662-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-09-17 |
| Classified | 2025-09-24 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 13,824 tubes |
| Reason classes | cgmp |
| NDC | 68462-0626, 68462-0626-52 |
| Lot numbers | 19252524 |
| Expiration dates | 2027-05-20 |
Product
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
Reason for recall
CGMP Deviations: Market complaints received for gritty texture (grainy)
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-0662-2025. 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.