Glenmark Pharmaceuticals recalls 3.125 mg Carvedilol Tablets due to nitrosamine impurity exceeding safety levels. This may pose health risks. Affected products include 500-count and 100-count bottles with specific NDC numbers and expiration dates.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals is recalling 3.125 mg Carvedilol Tablets because they contain a harmful nitrosamine impurity above safe levels. This could pose health risks to people taking the medication.
The tablets contain a nitrosamine impurity that exceeds the acceptable intake level. This impurity could potentially cause health issues when taken as directed.
People who have the recalled Carvedilol Tablets (3.125 mg) with specific NDC numbers and expiration dates are affected. Those taking this medication for blood pressure or heart conditions are most at risk.
Check for the product name 'Carvedilol Tablets, USP, 3.125 mg' in 500-count or 100-count bottles with NDC numbers 68462-162-05 or 68462-162-01. The expiration date is May 31, 2020 for the 500-count bottles and May 31, 2026 for the 100-count bottles.
Look for the NDC numbers 68462-162-05 (500-count) or 68462-162-01 (100-count) and expiration dates of May 31, 2020 or May 31, 2026.
The official recall notice states that the product contains a nitrosamine impurity above safe levels, so it is not safe to use.
The recall record does not specify a remedy, so the official notice does not state what action to take.
Check for the NDC numbers 68462-162-05 (500-count) or 68462-162-01 (100-count) and expiration dates of May 31, 2020 or May 31, 2026.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0577-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0577-2025 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.
