Carvedilol recalls

The FDA has published 19 recalls involving Carvedilol since 2013. The latest was reported on 27 Aug 2025. Most were for nitrosamine impurity. Glenmark Pharmaceuticals Inc., U 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 recalls19since 2013

Last 12 months0reported

Class I00% of total

Ongoing13latest 27 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 2 0 1Apr 0 4 0Jul 6 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 17 89%Class III 2 11%

Why carvedilol is recalled

Companies

By year

20251368%
202215%
2021211%
2019211%
201315%

Ongoing carvedilol recalls

13 active

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Drug	CLASS II	Carvedilol Tablets USP, 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., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 125 mg, Packaged as: a) recalledCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide

All carvedilol recalls, newest first

19 total

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Drug	CLASS II	Carvedilol Tablets USP, 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., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 125 mg, Packaged as: a) recalledCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 25 mg, a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 125mg Tablets a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	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.