FDAFDA · Food and drugs·Recall number 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.
Published June 4, 2025 · Recall initiated: February 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- U.S. Nationwide
- UPC
- 0368462162019
- Lot
- [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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.