Bumetanide recalls

The FDA has published 6 recalls involving Bumetanide since 2013. The latest was reported on 3 Jan 2024. Most were for potency & assay. Upsher Smith Laboratories 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 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why bumetanide is recalled

Companies

By year

2024117%
2018233%
2014233%
2013117%

All bumetanide recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024Drug	CLASS II	Bumetanide Tablets, USP, 2 mg recalled by Cardinal Healthcare	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
31 Oct 2018Drug	CLASS II	Bumetanide Tablets, USP, 1 mg recalled by Upsher Smith Laboratories	Upsher Smith Laboratories	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories	Upsher Smith Laboratories	Potency & Assay	Nationwide
29 Jan 2014Drug	CLASS II	Bumetanide, Tablet, 1 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Bumetanide, Tablet, 0.5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
18 Dec 2013Drug	CLASS III	Bumetanide Tablets USP 0.5 mg recalled by SandozBumetanide	Sandoz	Potency & Assay	Nationwide

Should you stop taking Bumetanide?

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.