FDAFDA · Food and drugs·Recall number D-0731-2026
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.
Published August 5, 2026 · Recall initiated: July 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide within the United States.
- UPC
- 0368462626528
- Lot
- Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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