Bisoprolol recalls

The FDA has published 6 recalls involving Bisoprolol since 2014. The latest was reported on 11 Feb 2026. Most were for potency & assay. 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 recalls6since 2014

Last 12 months2reported

Class I00% of total

Ongoing2latest 11 Feb 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 1 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 67%Class III 2 33%

Why bisoprolol is recalled

Companies

Brands

By year

2026117%
2025117%
2023117%
2021117%
2017117%
2014117%

Ongoing bisoprolol recalls

2 active

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Drug	CLASS II	Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Unichem Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide

All bisoprolol recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Drug	CLASS II	Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Unichem Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
8 Nov 2023Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Bisoprolol Fumarate And Hydrochlorothiazide Tablets 2.5 mg/6.25 mg recalledBisoprolol Fumarate And Hydrochlorothiazide	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
25 Oct 2017Drug	CLASS II	Bisoprolol Fumarate tablets, 5 mg recalledBisoprolol Fumarate	Unichem Pharmaceuticals Usa	Potency & Assay	Nationwide
22 Jan 2014Drug	CLASS II	Bisoprolol Fumarate Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Bisoprolol?

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.