Glenmark Pharmaceuticals recalls 12.5 mg Carvedilol tablets with NNCI impurity above FDA limits. Affected lots manufactured in India, expiring June 2026. Stop using immediately.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Glenmark Pharmaceuticals is recalling 12.5 mg Carvedilol tablets that contain an impurity (NNCI) exceeding FDA safety limits. This could pose a health risk to people taking the medication.
The tablets contain N-Nitroso Carvedilol Impurity-1 (NNCI) at levels above the FDA's safety limit of 4.0 ppm. This impurity could potentially cause health issues when taken by patients.
People with a prescription for Carvedilol tablets who received the recalled lots (17241257, 17241258, 17241279) from Glenmark. Those with heart conditions requiring this medication are most at risk.
Check your prescription label for the lot numbers 17241257, 17241258, or 17241279. The tablets are 12.5 mg, 500 per carton, and expire June 2026.
Discard all recalled Carvedilol tablets with lot numbers 17241257, 17241258, or 17241279.
The tablets contain N-Nitroso Carvedilol Impurity-1 (NNCI) at levels above the FDA's recommended limit of 4.0 ppm.
Check your prescription label for lot numbers 17241257, 17241258, or 17241279. The tablets are 12.5 mg, 500 per carton, and expire June 2026.
Yes, if you have a prescription for Carvedilol tablets and received the recalled lots, contact your doctor immediately to get a replacement.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0587-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0587-2025 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.
