Glenmark Carvedilol Tablets Recall: Nitroso Impurity Risk

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Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr, N/A · Mahwah, NJ 07430-2009

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Pharmaceuticals is recalling certain Carvedilol Tablets because they contain a harmful chemical impurity above safe levels. This impurity could cause health risks if taken as directed.

Why it’s dangerous

The tablets contain 'N-Nitroso Carvedilol I' impurities in amounts exceeding safe limits. This impurity can cause health problems when taken as prescribed, potentially leading to serious health effects.

Who’s affected

People with prescriptions for these specific Carvedilol tablets are affected. Those who have the recalled lots are at risk of health issues from the impurity.

How to tell if you have this one

Check your prescription label for Carvedilol Tablets 6.25 mg. The product comes in 100-count or 500-count bottles with specific lot numbers listed in the recall notice.

Brand
Glenmark
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard all recalled Carvedilol Tablets 6.25 mg bottles with the listed lot numbers.

✎ GovInfoNow

Questions people ask

What is the impurity in the recalled tablets?

The tablets contain 'N-Nitroso Carvedilol I' impurities above the recommended safe limit.

Which lots of Carvedilol tablets are affected?

Affected lots include 19231618 (exp Mar-25), 19232064 (exp Apr-25), and many others listed in the recall notice.

Do I need to contact my doctor?

Yes, if you have the recalled tablets, stop using them and contact your doctor for alternative treatment options.

Take action

Contact Glenmark

We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0449-2025 — Glenmark Glenmark

Hello,

I own a Glenmark that is covered by recall D-0449-2025 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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Where this comes from

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.

Official source: FDA Recall #D-0449-2025 (February 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0449-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx

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