Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel
- Recalling company
- Glenmark Pharmaceuticals Inc., USA
- 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
- CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 23, 2026
- Reported
- Aug 5, 2026
- Distribution
- Nationwide within the United States.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
- Company location
- Elmwood Park, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0731-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0731-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.