Glenmark Pharmaceuticals recalls Carvedilol 3.125mg tablets due to presence of N-Nitroso Carvedilol I impurity exceeding safe limits. Affected lots include 100-count and 500-count bottles with specific expiration dates.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals is recalling Carvedilol 3.125mg tablets because they contain an impurity (N-Nitroso Carvedilol I) that exceeds safe levels. This impurity could pose a health risk if taken as directed.
The tablets contain an impurity called 'N-Nitroso Carvedilol I' that exceeds the recommended safe intake level. This impurity could potentially cause health issues if the medication is taken as directed, though the exact risk level is not specified in the recall notice.
People who have the 100-count or 500-count bottles of Carvedilol 3.125mg tablets with specific lot numbers and expiration dates listed in the recall notice. Those taking this medication for blood pressure or heart conditions are most at risk.
Check for 100-count or 500-count bottles labeled 'Carvedilol Tablets USP 3.125mg' with lot numbers like 19231450 (expiring March 2025) or 19234275 (expiring September 2025).
Look for the product's lot number and expiration date on the bottle to confirm if it's affected.
The recall states the impurity exceeds the recommended safe intake limit, but the exact health risk is not specified in the notice.
Check the lot number and expiration date on the bottle. Affected lots include specific numbers like 19231450 (expiring March 2025) and 19234275 (expiring September 2025).
The recall does not specify a remedy, so contact your doctor or pharmacist for advice on whether to stop using the medication.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0448-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0448-2025 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.
