Unrated Drug recall · FDA · Published August 6, 2025

Glenmark Carvedilol Tablets Recall: NNCI Impurity Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0588-2025Drug Glenmark ›

Recall notice

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/31881-glenmark-carvedilol-tablets-recall-nnci-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31881-glenmark-carvedilol-tablets-recall-nnci-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0588-2025

Cite this page

“Glenmark Carvedilol Tablets Recall: NNCI Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31881-glenmark-carvedilol-tablets-recall-nnci-impurity-risk. Based on FDA recall #D-0588-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0588-2025%22&limit=1).

The FDA announced on August 6, 2025, that Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets, USP, 25 mg due to CGMP deviations involving N-Nitroso Carvedilol Impurity-1 levels exceeding the recommended limit. The recall affects 14,976 bottles distributed nationwide.

How to tell if you have it

Brand: Glenmark
Product: Carvedilol Tablets, USP, 25 mg
Quantity: 500 Tablets per carton
NDC: 68462-165-05
Lot Codes: 17241213, 17241215, 17241224
Expiration Date: 06/2026

The hazard

The recall is due to CGMP deviations where results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity were observed to be above the FDA-recommended limit of not more than (NMT) 4.0 ppm.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since November 20, 2017. Other recent recalls include the July 23, 2026 Glenmark Azelaic Acid Gel recall for grainy texture risk and the May 27, 2026 Glenmark Alyacen Birth Control Tablets recall for impurities risk. Similar recent recalls of other products include the January 21, 2026 Unichem Bisoprolol/Hydrochlorothiazide Tablets recall, the August 5, 2026 Zydus Mirabegron 25mg Tablets recall, and the April 21, 2026 Breckenridge Duloxetine Capsules recall, all citing N-nitroso impurity risks.

How to tell if you have this one

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.

Brand
Glenmark
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide within the USA
NDC
68462-162-60, 68462-162-01, 68462-162-18, 68462-162-05, 68462-162-10, 68462-163-60, 68462-163-01, 68462-163-18, 68462-163-05, 68462-163-10, 68462-164-60, 68462-164-01, 68462-164-18, 68462-164-05, 68462-164-10, 68462-165-60, 68462-165-01, 68462-165-18, 68462-165-05, 68462-165-10

Recall number	Product, codes & lots	Quantity
D-0587-2025	Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05; Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026	17, 496 bottles
D-0588-2025	Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05; Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026	14,976 bottles

Based on the official FDA remedy

What to do — step by step

Check Your Lot Number
Look for lot numbers 17241213, 17241215, or 17241224 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 14 days after the firm started it.

Aug 6, 2025Firm started the recall
Aug 14, 2025FDA classified it Class II
Aug 20, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31881-glenmark-carvedilol-tablets-recall-nnci-impurity-risk">Glenmark Carvedilol Tablets Recall: NNCI Impurity Risk (GovInfoNow)</a>

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-0588-2025 (August 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0588-2025 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.