Glenmark Pharmaceuticals recalls 25mg Carvedilol Tablets (NDC 68462-165-05 and 68462-165-01) due to N-Nitroso Carvedilol I impurity exceeding FDA limits. Affected lots manufactured between 2023-2026.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals is recalling 25mg Carvedilol Tablets that contain an impurity (NNCI-I) exceeding FDA safety limits. This could pose a health risk to patients taking the medication.
The recall is for an impurity called N-Nitroso Carvedilol I (NNCI-I) that was found in levels exceeding the FDA's recommended safety limits. This impurity could potentially cause health risks when taken by patients.
Patients prescribed Carvedilol Tablets by a doctor who received the recalled lots (NDC 68462-165-05 or 68462-165-01) between 2023 and 2026. Those with specific medical conditions requiring this medication are most at risk.
Check if your Carvedilol Tablets have the NDC numbers 68462-165-05 (500 tablets) or 68462-165-01 (100 tablets). Look for lot numbers listed in the recall notice, which range from 17230500 to 17240510 with expiration dates from February 2025 through February 2026.
Verify if your Carvedilol Tablets have the NDC numbers 68462-165-05 or 68462-165-01 and the specific lot numbers listed in the recall notice.
The recall is due to N-Nitroso Carvedilol I (NNCI-I) impurities found in levels exceeding the FDA's recommended safety limits.
The official recall notice does not specify a remedy or action for affected patients.
Affected lots have NDC numbers 68462-165-05 (500 tablets) and 68462-165-01 (100 tablets) with lot numbers ranging from 17230500 to 17240510, expiring between February 2025 and February 2026.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0215-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0215-2025 from Glenmark Pharmaceuticals. 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.
