Azelaic Acid Gel Recall Due to Manufacturing Quality Defect
Glenmark Pharmaceuticals recalls 13,824 tubes of Azelaic Acid Gel due to complaints of gritty texture resulting from manufacturing process deviations.
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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The identified hazard is a product quality issue (gritty texture) stemming from manufacturing deviations, with no evidence of actual harm.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel, 15%, 50 grams (batch #19252524, expiration date May 2027) nationwide due to market complaints of gritty texture. The recall stems from deviations in Current Good Manufacturing Practice (CGMP).
The recall affects 13,824 tubes distributed nationwide within the United States. The product is a prescription topical medication (Rx only) manufactured by Glenmark Pharmaceuticals Limited in Colvale-Bardez, Goa, India, and distributed by Glenmark Pharmaceuticals Inc., USA.
Patients currently using this product should not discontinue use without consulting their healthcare provider. Consumers with affected batches should contact their pharmacist or Glenmark Pharmaceuticals for guidance on obtaining a replacement or alternative medication. Adverse events or quality concerns can be reported to the FDA via MedWatch.
The recalled product
- Product
- AZELAIC ACID (AZELAIC ACID)
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical / Dermatological
- Hazard
- texture-defect
- manufacturing-defect
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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