Glenmark Pharmaceuticals recalls 12.5 mg Carvedilol tablets due to nitrosamine impurity exceeding safe levels. Consumers with the specific NDC 68462-164-05 lot 19243202 should stop using and contact for details.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals is recalling 12.5 mg Carvedilol tablets that contain a harmful nitrosamine impurity above safe levels. This impurity could pose health risks with long-term use, so affected consumers should stop using the product immediately.
The tablets contain a nitrosamine impurity that exceeds the safe intake level. Nitrosamines are known carcinogens that can increase cancer risk with long-term exposure. This impurity was found during manufacturing quality checks.
People with a prescription for the recalled 12.5 mg Carvedilol tablets (NDC 68462-164-05, lot 19243202) who have the 500-count bottle. Those with higher doses or different formulations are not affected.
Check for the product name 'Carvedilol Tablets, USP, 12.5 mg, 500-count bottle' with NDC code 68462-164-05 and lot number 19243202. The product is prescription-only and manufactured by Glenmark Pharmaceuticals Ltd in India.
Immediately stop using the recalled Carvedilol tablets with NDC 68462-164-05 and lot 19243202.
No, the recalled product contains a nitrosamine impurity that exceeds safe levels. Do not use it.
Look for the NDC code 68462-164-05 and lot number 19243202 on the bottle. The product is a 500-count bottle of 12.5 mg Carvedilol tablets, prescription-only.
Stop using it immediately and contact Glenmark Pharmaceuticals for instructions on returning the product.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0578-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0578-2025 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.
