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.
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
|---|---|
| Reason | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 5, 2026 |
| Initiated | Jul 23, 2026 |
| Region | NJ, United States |
| Distribution | Nationwide within the United States. |
| Quantity | N/A |
| Code/Lot | Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0731-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0731-2026)
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