Reported Jun 4, 2025 · Ongoing
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),…
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 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only
- Manufactured byGlenmark Pharmaceuticals Ltd
- Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 [100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25 2 Lot 19234275, Exp Sep-25 3 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 4 Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25 5 Lot 19234275, Exp Sep-25 6 Lots 19234843, 19235039, Exp Nov-25 7 Lots 19240280, 19240296, Dec-25 - Amount recalled
- [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
This product could cause temporary or reversible health problems — stop using it.
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