Glenmark Pharmaceuticals recalls 25mg Carvedilol tablets due to NNCI impurity exceeding FDA limits. Affected lots manufactured in India for US sale. Consumers should contact pharmacy for safe alternatives.
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 25mg Carvedilol tablets that may contain an impurity exceeding FDA safety limits. This could pose a health risk if taken as prescribed. The recall affects specific lots manufactured in India for US distribution.
The tablets may contain N-Nitroso Carvedilol Impurity-1 (NNCI) at levels above the FDA's recommended limit of 4.0 ppm. This impurity could potentially cause health issues if taken as prescribed, though the exact risk level isn't specified in the recall notice.
People with prescriptions for Carvedilol tablets from Glenmark Pharmaceuticals Inc. in the US. Those with specific lot numbers (17241213, 17241215, 17241224) produced in India for US sale are most at risk.
Check your Carvedilol tablets for the lot numbers 17241213, 17241215, or 17241224. These were manufactured in India for US distribution with expiration dates through June 2026.
Look for lot numbers 17241213, 17241215, or 17241224 on the packaging.
The recall states the impurity level exceeds FDA limits, but the exact health risk isn't specified. The official notice doesn't state if this could cause serious injury.
Check the lot number on your Carvedilol tablets. Affected lots are 17241213, 17241215, or 17241224.
The recall notice doesn't specify a remedy. You should contact your pharmacy for safe alternatives.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0588-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0588-2025 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.
