FDAHealthJuly 23, 2026
Glenmark Pharmaceuticals Inc., USA — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 23, 2026
Nationwide within the United States.
What's affected?
- 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.
- Brand
- AZELAIC ACID
- UPC
- 0368462626528
- Lot code
- 19260937A
Additional details
Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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