Reported Jun 4, 2025 · Ongoing
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx…
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 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only
- Manufactured byGlenmark Pharmaceuticals Ltd
- Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 [100-Count Bottles] Lot 19231618, exp Mar-25 2 19232064, exp Apr-25 3 19232324, May-25 4 19233369, Exp Jul-25 5 Lot 19234162, Exp Sep-25 6 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 7 Lots 19232736, 19232743, 19232746, 19232756, 19232757, Exp Jun-25 8 Lots 19233369, 19233371, 19233405, 19233416, Exp Jul-25 9 Lots 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, Exp Sep-25 10 Lots 19234743, 19234774, 19234993, Exp Nov-25 11 Lots 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319, Exp Dec-25 12 Lot 19240543, Exp Jan-26 - Amount recalled
- [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Glenmark Pharmaceuticals Inc., USA recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.