Glenmark Pharmaceuticals recalls 12.5 mg Carvedilol tablets due to unsafe impurity levels. Affected lots expire April-June 2025. Stop using immediately if you have these specific batches.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals is recalling 12.5 mg Carvedilol tablets that contain an impurity above safe limits. This impurity could pose health risks if taken as directed. Affected products have specific lot numbers expiring between April and June 2025.
The tablets contain an impurity called 'N-Nitroso Carvedilol I' at levels above what's considered safe. This impurity could potentially cause health issues if taken as directed. The exact health risk isn't specified in the recall notice.
People with prescriptions for Carvedilol tablets from Glenmark Pharmaceuticals. Those with the specific lot numbers listed in the recall are most at risk.
Check your Carvedilol tablets for the lot numbers listed: 19231899, 19231922, 19231927, 19231967, 19231979 (expiring April 2025) or 19232226, 19232234, 19232265, 1923227 (expiring May 2025) or 19232758, 19232759, 19232762, 19232788 (expiring June 2025).
Look for the lot numbers listed in the recall: 19231899, 19231922, 19231927, 19231967, 19231979 (expiring April 2025) or 19232226, 19232234, 19232265, 1923227 (expiring May 2025) or 19232758, 19232759, 19232762, 19232788 (expiring June 2025).
The recall states the impurity is above the recommended acceptable intake limit, but the exact health risk isn't specified.
Check your Carvedilol tablets for the specific lot numbers listed in the recall: 19231899, 19231922, 19231927, 19231967, 19231979 (expiring April 2025) or 19232226, 19232234, 19232265, 1923227 (expiring May 2025) or 19232758, 19232759, 19232762, 19232788 (expiring June 2025).
The recall does not specify a remedy, so you should contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0450-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0450-2025 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.
