Glenmark Carvedilol Tablets Recall: Nitrosamine Impurity Risk
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.
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CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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What happened, in plain English
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. Read more at govinfonow.com/recall/31878-glenmark-carvedilol-tablets-recall-nitrosamine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31878-glenmark-carvedilol-tablets-recall-nitrosamine-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0578-2025
Cite this page
“Glenmark Carvedilol Tablets Recall: Nitrosamine Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/31878-glenmark-carvedilol-tablets-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0578-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0578-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Glenmark- Category
Drug
All 3 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 in 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-0577-2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.; Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026 | 44,328 bottles |
| D-0578-2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05; Lot#:19243202, Exp: 7/31/2026. | 6,432 bottles |
| D-0579-2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05; Lot#:19243104, Expires: 7/31/2026. | 4,800 bottles |
What to do — step by step
Stop using it now
Immediately stop using the recalled Carvedilol tablets with NDC 68462-164-05 and lot 19243202.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in 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 13 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0578-2025 (August 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0578-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.