Carvedilol recalls

Carvedilol products have been recalled 17 times, most recently on 27 Aug 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., USA. The most common reason is nitrosamine impurity.

Total recalls17since 2019

Last 12 months0reported

Class I00% of total

Ongoing13latest 27 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 2Feb 0 1 0May 4 0 6Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 15 88%Class III 2 12%

Why carvedilol is recalled

Companies

Product types

Blood Pressure Medication17100%

By year

20251376%
2021212%
2019212%

Ongoing carvedilol recalls

13 active

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
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide

All carvedilol recalls, newest first

17 total

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
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 6.25 mg, a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 3.125mg Tablets a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
16 Apr 2025Drug	CLASS II	Carvedilol Tablets, USP 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
12 Feb 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
12 Feb 2025Drug	CLASS II	Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
1 Dec 2021Drug	CLASS III	Carvedilol Tablets, USP, 6.25 mg recalled by Aurobindo Pharma USACarvedilol	Aurobindo Pharma USA	Potency & Assay	Nationwide
25 Aug 2021Drug	CLASS II	Carvedilol Tablets, USP 25 mg recalled by Zydus Pharmaceuticals (USA)Carvedilol	Zydus Pharmaceuticals	Other	Nationwide
15 May 2019Drug	CLASS II	Carvedilol Tablets, USP, 6.25 mg recalled by Zydus Pharmaceuticals USACarvedilol	Zydus Pharmaceuticals USA	Packaging Defects	Nationwide
1 May 2019Drug	CLASS III	Carvedilol Tablets, USP, 3.125 mg recalled by Zydus Pharmaceuticals USACarvedilol	Zydus Pharmaceuticals USA	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.