Glenmark recalls 12.5 mg Carvedilol Tablets due to NNCI-I impurity exceeding FDA limits. Affected lots from 2023-2026; stop using if you have these specific NDC numbers.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Glenmark is recalling 12.5 mg Carvedilol Tablets that contain an impurity (NNCI-I) exceeding FDA safety limits. This could pose a health risk if taken as prescribed. Affected products have specific NDC numbers and expiration dates listed in the recall notice.
The recall is for a chemical impurity (NNCI-I) found in the medication that exceeds the FDA's recommended safety limits. This impurity could potentially cause health issues if the medication is taken as directed.
People with prescriptions for these specific Carvedilol tablets from Glenmark. Those who have the listed NDC numbers and expiration dates are most at risk.
Check your Carvedilol tablets for NDC numbers 68462-164-05 (500 tablets) or 68462-164-01 (100 tablets). The products were manufactured between 2023 and 2026 with specific expiration dates listed in the recall notice.
Identify your Carvedilol tablets by NDC numbers: 68462-164-05 (500 tablets) or 68462-164-01 (100 tablets).
Talk to your doctor or pharmacist about whether you have the recalled tablets and if you need to stop taking them.
The FDA found NNCI-I impurities in these Carvedilol tablets that exceed the recommended safety limits.
Check your product's NDC number and expiration date. Contact your healthcare provider to discuss whether you need to stop taking them.
Yes, the recalled products have specific expiration dates from February 2025 through January 2026, depending on the batch.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0216-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0216-2025 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.
