Reported Feb 12, 2025 · Ongoing
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01,…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- 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 codes and dates
- Lot numbers
a) 17230658Exp.: 02/20251723081417230822Exp.: 03/2025172310041723100917231022Exp.: 04/20251723139317231392Exp.: 05/2025172315381723154117231542Exp.: 06/20251723171017231718172317211723172217231730
- Exp'
07/202517232169Exp.: 09/202517232253Exp.: 10/20251724022017240240Exp.: 01/202617240459Exp.: 02/2026 b) 17230814Exp.: 03/202517231392Exp.:05/202517232260Exp.: 10/2025
- Lot numbers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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