Azelaic acid gel recalled after complaints of gritty texture in tubes
Glenmark Azelaic Acid Gel, 15%, 50 gram tubes from batch 19252524, is recalled nationwide after market complaints of a gritty or grainy texture. 13,824 tubes are affected.
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: Rubric level 2 covers precautionary recalls; the notice describes a texture complaint with no health consequence stated.
Plain-English summary
Azelaic Acid Gel, 15%, in 50 gram tubes for topical use on prescription only, manufactured by Glenmark Pharmaceuticals Limited in Colvale-Bardez, Goa, India for Glenmark Pharmaceuticals Inc., USA of Mahwah, New Jersey, NDC 68462-626-52, is being recalled. The affected product is batch 19252524 with an expiry of May 2027, and the recall covers 13,824 tubes distributed nationwide.
The recall follows current good manufacturing practice deviations, after market complaints were received for a gritty or grainy texture. The FDA classified the action as Class II.
Patients should check the batch number on their tube against the recall and can speak to their pharmacist about a replacement supply.
The recalled product
- Product
- AZELAIC ACID (AZELAIC ACID)
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical
- Affected units
- 13,824
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 (2)
- Batch # 19252524
- Exp Date: May 2027
UPCs (1)
- 0368462626528
Distribution
Distributed nationwide across the United States.
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