CLASS II ONGOING Drug recall · Reported 4 Jun 2025 · FDA Enforcement Report

Carvedilol Tablets USP 6.25 mg, a.) bottle recalled

Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg, a.) bottle (, distributed nationwide in the US. The recall was initiated on 28 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes[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

NDC68462-162, 68462-163, 68462-164, 68462-165

UPC0368462162019, 0368462163016, 0368462164013, 0368462165010

Quantity recalled[100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0449-2025
FDA event ID: 96861
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Brand: Carvedilol
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2025
FDA classified: 28 May 2025
Reported: 4 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

28 Feb 2025	Recall initiated by company
28 May 2025	Classified by FDA	+89 days
4 Jun 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Which lots are affected?

[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

Where was it sold?

U.S. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 96861

This product is part of a recall event; the main page for the event is Carvedilol Tablets USP 25 mg recalled by Glenmark Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025	CLASS II	Carvedilol Tablets USP 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025	CLASS II	Carvedilol Tablets USP 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025	CLASS II	Carvedilol Tablets USP 3.125mg Tablets a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide

More recalls from Glenmark Pharmaceuticals Inc., USA

All 141

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Drug	CLASS II	Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide

Other Carvedilol recalls

All 22

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Drug	CLASS II	Carvedilol Tablets USP, 12.5 mg recalled by The Harvard Drug GroupCarvedilol	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 3.125 mg, Packaged as: a) recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide