Glenmark Pharmaceuticals recalls 25mg Carvedilol tablets due to nitrosamine impurity exceeding safe levels. This may pose health risks. Consumers should contact the company for details.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals is recalling 25 mg Carvedilol tablets that contain a nitrosamine impurity above safe levels. This impurity could pose health risks to users, especially those with certain medical conditions.
The tablets contain a nitrosamine impurity that exceeds the acceptable intake level. Nitrosamines are known to be harmful and can cause health issues, particularly in people with certain medical conditions.
People who have the 25 mg Carvedilol tablets with NDC 68462-165-05 and lot number 19243104 are affected. Those with heart conditions or on blood pressure medication are at higher risk.
Check for the product name 'Carvedilol Tablets, USP, 25 mg, 500-count bottle' with NDC 68462-165-05 and lot number 19243104. These tablets are prescription-only and sold by Glenmark Pharmaceuticals.
Reach out to Glenmark Pharmaceuticals for specific instructions on how to return or dispose of the recalled tablets.
The recall indicates a potential health risk due to a nitrosamine impurity exceeding safe levels. The manufacturer advises contacting them for specific instructions.
Look for the product name 'Carvedilol Tablets, USP, 25 mg, 500-count bottle' with NDC 68462-165-05 and lot number 19243104.
Contact Glenmark Pharmaceuticals for instructions on returning or disposing of the tablets.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0579-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0579-2025 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.
