Glenmark Pharmaceuticals recalls 25mg Carvedilol tablets due to unsafe impurity levels. Affected lots expire Feb 2025 or Jan 2026. Stop using immediately if you have these specific lots.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals is recalling 25mg Carvedilol tablets that contain an impurity above safe levels. This impurity could pose a health risk if taken as directed. Affected products have specific lot numbers and expiration dates.
The tablets contain an impurity called 'N-Nitroso Carvedilol I' in amounts exceeding the safe limit. This impurity could potentially cause health issues if taken as prescribed. The impurity is a result of manufacturing deviations.
People with prescriptions for these specific lots of Carvedilol tablets are affected. Those who have the listed lot numbers and expiration dates are most at risk.
Check the lot number and expiration date on the bottle. Affected lots include 19231107, 19231114, 19231152 (expiring Feb 2025) and 19234866 (expiring Jan 2026).
Look for lot numbers 19231107, 19231114, 19231152 (expiring Feb 2025) or 19234866 (expiring Jan 2026) on the bottle.
The recall is due to manufacturing deviations that resulted in an impurity called 'N-Nitroso Carvedilol I' exceeding safe levels.
The official recall notice does not specify a remedy, so contact your doctor or pharmacist for guidance.
The recall only applies to the specific lots listed in the notice.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0451-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0451-2025 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.
