Reported Feb 12, 2025 · Ongoing
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01,…
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, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
- Lot codes and dates
- Lot numbers
72 of 72 codes
a) 17230500172305091723052617230546172305511723060317230628172306421723064517230681Exp.:02/20251723082917230832172308541723086417230874172308761723088917230894Exp.: 03/202517230960172309641723097617230981172309851723116117231171Exp.: 04/2025 1723131517231318172313321723133317231365Exp.: 05/20251723153917231563Exp.: 06/20251723165317231662172316631723168017231691172317811723178217231789Exp.: 07/20251723183817231880Exp.: 08/2025172321441723214717232151Exp.: 09/20251723236917232370172324081723240917232416172325041723252217232531
- 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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