Glenmark Recalls Carvedilol 12.5mg Tablets Due to Impurity
Glenmark Pharmaceuticals recalls specific lots of Carvedilol Tablets, USP, 12.5 mg due to CGMP deviations and failing impurity limits.
Use caution until it’s fixed
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Carvedilol Tablets, USP, 12.5 mg because they failed current FDA recommended limits for N-Nitroso Carvedilol I impurity (NNCI-I). The recall covers both 500-tablet and 100-tablet bottles distributed nationwide in the U.S. No specific remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/32323-glenmark-recalls-carvedilol-12-5mg-tablets-due-to-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/32323-glenmark-recalls-carvedilol-12-5mg-tablets-due-to-impurity · Updated October 9, 2026 · FDA enforcement record: FDA #D-0216-2025
Cite this page
“Glenmark Recalls Carvedilol 12.5mg Tablets Due to Impurity.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32323-glenmark-recalls-carvedilol-12-5mg-tablets-due-to-impurity. Based on FDA recall #D-0216-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0216-2025%22&limit=1).
Why it’s dangerous
The recalled tablets contain N-Nitroso Carvedilol I impurity (NNCI-I) that exceeds current FDA recommended limits. This is a Good Manufacturing Practice (CGMP) deviation, indicating the product does not meet quality standards for purity.
Who’s affected
Patients who have been prescribed Carvedilol Tablets, USP, 12.5 mg and possess one of the listed lot numbers with expiration dates ranging from March 2025 to February 2026.
How to tell if you have this one
Check your prescription bottle for Glenmark Pharmaceuticals branding and the specific NDC numbers: 68462-164-05 (500 Tablets) or 68462-164-01 (100 Tablets). Verify if your lot number matches any of the following: 17230814, 17230822, 17231004, 17231009, 17231022, 17231392, 17231393, 17231538, 17231541, 17231542, 17231710, 17231718, 17231721, 17231722, 17231730, 17232169, 17232253, 17232260, 17240220, 17240240, or 17240459.
- Brand
Glenmark Pharmaceuticals- Category
Drug
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 in the U.S- 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-0215-2025 | Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.; Lot numbers: a) 17230500, 17230509,17230526,17230546,17230551,17230603,17230628, 17230642,17230645,17230681, Exp.:02/2025; 17230829,17230832,17230854, 17230864,17230874,17230876,17230889,17230894, Exp.: 03/2025; 17230960, 17230964,17230976,17230981,17230985,17231161,17231171, Exp.: 04/2025 17231315,17231318,17231332,17231333,17231365, Exp.: 05/2025; 17231539, 17231563, Exp.: 06/2025; 17231653,17231662,17231663,17231680,17231691, 17231781,17231782,17231789, Exp.: 07/2025;17231838,17231880, Exp.: 08/2025; 17232144,17232147,17232151, Exp.: 09/2025; 17232369,17232370,17232408,17232409, 17232416,17232504,17232522,17232531,17232538,17232543, Exp.: 11/2025; 17240377,17240385,17240415,17240422,17240430,17240510, Exp.: 02/2026. b) 17230551, 17240377, Exp.:02/2025 | — |
| D-0216-2025 | Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.; Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025. | — |
What to do — step by step
Check Your Lot Number
Compare the lot number on your Carvedilol bottle against the list of recalled lots provided in the record.
Contact Your Pharmacist
If you have a recalled lot, contact your pharmacy or healthcare provider to discuss next steps, as no specific remedy is stated in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 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-0216-2025 (January 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0216-2025 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.