Azelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
Glenmark Pharmaceuticals is recalling azelaic acid gel 15% after receiving complaints that the product felt grainy, gritty, or sandy. The nationwide recall covers specific lots with expiration dates from February through April 2028.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this recall as Class II, and the source reports no illnesses, injuries, or hospitalizations. Under the rubric, Class II without hospitalization reports is Moderate, not Severe.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel, 15%, 50 gram tubes, a prescription topical product. The recall is nationwide and affects specific lots: 19260937A (exp. February 2028), 19261225A and 19261185A (exp. March 2028), and 19261664A and 19261682A (exp. April 2028). The product is distributed by Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
The recall was initiated because of CGMP deviations: the firm received product quality complaints describing abnormal texture or consistency, specifically grainy, gritty, or sandy. The FDA has classified this as a Class II recall.
Patients who have one of the listed lots should contact their pharmacist or the recalling firm for guidance. The recall notice does not include specific return or disposal instructions.
The recalled product
- Product
- AZELAIC ACID (AZELAIC ACID)
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical Prescription Gel
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 19260937A
- Exp. Date February 2028
- 19261225A
- 19261185A
- Exp. Date March 2028
- 19261664A
- 19261682A
- Exp. Date April 2028.
UPCs (1)
- 0368462626528
Distribution
Distributed nationwide across the United States.
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