Carvedilol recalls

The FDA has published 22 recalls involving Carvedilol since 2013. The latest was reported on 27 Aug 2025. Most were for nitrosamine impurity. Glenmark Pharmaceuticals Inc., USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls22since 2013

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 20 91%Class III 2 9%

Why carvedilol is recalled

Companies

By year

20251359%
202215%
2021314%
201929%
201515%
201415%
201315%

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

22 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
23 Nov 2022Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Viatris	Viatris	Other	Nationwide
1 Dec 2021Drug	CLASS III	Carvedilol Tablets, USP, 6.25 mg recalled by Aurobindo Pharma USACarvedilol	Aurobindo Pharma USA	Potency & Assay	Nationwide
1 Sep 2021Drug	CLASS II	Carvedilol 25 mg recalled by RemedyRepack	RemedyRepack	Packaging Defects	FL, VA
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
20 May 2015Drug	CLASS II	Carvedilol 1.25 mg/mL, Health Innov Pharmacy recalled	Health Innovations Pharmacy	Sterility	NC
29 Jan 2014Drug	CLASS II	Carvedilol Phosphate ER, Capsule, 20 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
6 Feb 2013Drug	CLASS II	Carvedilol Tablets recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Other	Nationwide

Should you stop taking Carvedilol?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.