Glenmark Recalls Carvedilol 25mg Due to Impurity Risk
Glenmark recalls specific lots of Carvedilol Tablets USP 25 mg due to CGMP deviations and an impurity above safe limits. Check your bottle's lot number.
Use caution until it’s fixed
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals Inc., USA is recalling a specific batch of Carvedilol Tablets USP 25 mg because manufacturing quality control issues led to the presence of 'N-Nitroso Carvedilol I' impurity above the recommended acceptable intake limit. The recall affects 18,696 bottles distributed nationwide. This impurity poses a potential health risk if consumed over time. Read more at govinfonow.com/recall/32254-glenmark-recalls-carvedilol-25mg-due-to-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32254-glenmark-recalls-carvedilol-25mg-due-to-impurity-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0451-2025
Cite this page
“Glenmark Recalls Carvedilol 25mg Due to Impurity Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32254-glenmark-recalls-carvedilol-25mg-due-to-impurity-risk. Based on FDA recall #D-0451-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0451-2025%22&limit=1).
Why it’s dangerous
The product contains 'N-Nitroso Carvedilol I,' an impurity that exceeds the recommended acceptable intake limit due to Current Good Manufacturing Practice (CGMP) deviations. While the record does not specify immediate acute symptoms, exposure to impurities above safe limits can pose long-term health risks.
Who’s affected
Patients in the United States who have been prescribed or possess Glenmark Pharmaceuticals' Carvedilol Tablets USP 25 mg from the specific lots listed below. Individuals taking this medication for heart conditions are the primary group affected.
How to tell if you have this one
Check your medication bottle for the following details: Product is Carvedilol Tablets USP 25 mg, Rx Only. Manufacturer is Glenmark Pharmaceuticals Ltd., manufactured for Glenmark Pharmaceuticals Inc., USA in Mahwah, NJ. Look for NDC 68462-165-05 and one of these Lot/Expiry combinations: Lots 19231107, 19231114, or 19231152 expiring Feb-25; or Lot 19234866 expiring Jan-26.
- Brand
Glenmark Pharmaceuticals- Category
Drug
All 4 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
U.S. Nationwide- 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-0448-2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.; [100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843, 19235039, Exp Nov-25; Lots 19240280, 19240296, Dec-25 | [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles |
| D-0449-2025 | Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.; [100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, 19231448, Exp Mar-25, 19232043,19232051,19232064, Apr-25, 19232322, 19232324, 19232365, 19232380, 19232389, Exp May-25; Lots 19232736, 19232743, 19232746, 19232756, 19232757, Exp Jun-25; Lots 19233369, 19233371, 19233405, 19233416, Exp Jul-25; Lots 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, Exp Sep-25; Lots 19234743, 19234774, 19234993, Exp Nov-25; Lots 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319, Exp Dec-25; Lot 19240543, Exp Jan-26 | [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles |
| D-0450-2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05; Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25 | 84,048 bottles |
| D-0451-2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.; Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26 | 18,696 bottles |
What to do — step by step
Check Your Bottle
Verify if your Carvedilol Tablets USP 25 mg bottle matches the NDC and lot numbers listed in the recall details.
Contact Your Pharmacist
If you have one of the affected lots, contact your pharmacist or healthcare provider immediately to discuss alternatives or a replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months 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.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the affected product is 68462-165-05.
How many bottles are being recalled?
A total of 18,696 bottles are included in this recall.
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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-0451-2025 (February 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0451-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.