Prescription azelaic acid gel recalled for manufacturing process deviations
Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.
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: This is an FDA Class II recall for manufacturing deviations without reported illnesses, injuries, or hospitalizations. Per the rubric, FDA Class II without hospitalization reports scores lower than 4, and a theoretical manufacturing hazard with no reported harm scores at most 3. The voluntary, precautionary nature of the recall supports a Moderate (2) classification.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel 15% (50-gram containers) nationwide. The affected lot is 19241453 with an expiration date of March 2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This is a voluntary, firm-initiated recall.
Azelaic Acid Gel is a prescription topical medication. Patients currently using this medication from the affected lot should consult their healthcare provider before taking any action. Healthcare providers should advise patients on appropriate next steps based on their individual medical needs.
The recalled product
- Product
- AZELAIC ACID (AZELAIC ACID)
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical
- Hazard
- manufacturing-deviation
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)
- Lot# 19241453
- Exp MARCH 2026
UPCs (1)
- 0368462626528
Distribution
Distributed nationwide across the United States.
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