Glenmark Pharmaceuticals recalls 1000mg Metformin Hydrochloride Extended-Release Tablets due to CGMP deviations. Affected lots manufactured in India for US distribution. No specific remedy stated in recall notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 1000mg Metformin Hydrochlor: 90-count bottles made in India for US sale because of manufacturing quality control issues. This recall does not involve a specific safety risk to consumers but follows regulatory compliance procedures.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which are regulatory quality control issues. These deviations do not indicate a specific safety hazard to consumers but are part of the pharmaceutical manufacturing compliance process.
People who purchased the 1000mg Metformin Hydrochloride Extended-Release Tablets 90-count bottles from Glenmark Pharmaceuticals in the US. Those with diabetes who take this medication are most at risk.
Check for the 1000mg Metformin Hydrochloride Extended-Release Tablets 90-count bottle with NDC 68462-521-90. The lot numbers 17232088 or 17232093 with expiration dates of September 25, 2025.
Verify the product label for NDC 68462-521-90 and lot numbers 17232088 or 17232093.
The recall is for CGMP deviations, which are manufacturing quality control issues. The official notice does not state a specific safety risk to consumers.
The recall notice does not specify any remedy or action steps for consumers.
Look for the NDC code 68462-521-90 and lot numbers 17232088 or 17232093 on the product label.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0328-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0328-2025 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.
