Glenmark Pharmaceuticals recalls 15% azelaic acid gel (50g, Rx only) due to CGMP deviations. Affected lots manufactured in India for US sale. No specific remedy stated in recall notice.
CGMP Deviations
Glenmark is recalling 15% azelaic acid gel (5:00 grams, prescription-only) because of manufacturing quality control issues. This recall does not involve immediate safety risks to consumers but requires action to prevent potential product issues.
CGMP deviations refer to manufacturing quality control failures. This means the product may not meet safety and quality standards, though the recall does not specify immediate health risks.
Prescription users of Glenmark's 15% azelaic acid gel (50g) in the US. Those who have the specific lot number 19241453 are most at risk.
Check for the lot number 19241453 on the product label. The product is a 50g prescription-only azelaic acid gel with NDC 68462-626-52.
Look for the lot number 19241453 on the gel's label to confirm if it's affected.
The recall states there were CGMP deviations, but does not specify immediate safety risks. The product may not meet quality standards.
The recall does not provide specific remedy steps. Check the product label for the lot number 19241453 to determine if it's affected.
The recall notice does not mention any remedy for replacements or returns.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0621-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0621-2024 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
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