Furosemide recalls

The FDA has published 11 recalls involving Furosemide since 2013. The latest was reported on 29 Apr 2026. Most were for sterility. Boehringer Ingelheim Roxane 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 recalls11since 2013

Last 12 months2reported

Class I00% of total

Ongoing3latest 29 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 1 0Feb 0 1 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 9 82%Class III 2 18%

Why furosemide is recalled

Companies

By year

2026218%
201719%
2015327%
2013545%

Ongoing furosemide recalls

3 active

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Drug	CLASS II	Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide	Leading Pharma	Nitrosamine Impurity	Nationwide
28 Jan 2026Drug	CLASS II	Furosemide Tablets, USP 40 mg recalled by Graviti PharmaceuticalsFurosemide	Graviti Pharmaceuticals Private	Other	Nationwide
17 Jul 2013Drug	CLASS II	Furosemide 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All furosemide recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Drug	CLASS II	Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide	Leading Pharma	Nitrosamine Impurity	Nationwide
28 Jan 2026Drug	CLASS II	Furosemide Tablets, USP 40 mg recalled by Graviti PharmaceuticalsFurosemide	Graviti Pharmaceuticals Private	Other	Nationwide
1 Feb 2017Drug	CLASS II	Furosemide Tablets USP, 20 mg recalled by Roxane LaboratoriesFurosemide	Roxane Laboratories	Other	Nationwide
9 Dec 2015Drug	CLASS II	Furosemide 20 mg/mL svn Sol, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
21 Oct 2015Drug	CLASS III	Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide	Boehringer Ingelheim Roxane	Manufacturing (CGMP) Deviations	Nationwide
21 Oct 2015Drug	CLASS III	Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide	Boehringer Ingelheim Roxane	Manufacturing (CGMP) Deviations	Nationwide
18 Sep 2013Drug	CLASS II	Furosemide 10 MG/ML Injectable, all presentations recalled	Beacon Hill Medical Pharmacy, P.C	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Furosemide 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
22 May 2013Drug	CLASS II	Furosemide Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide
15 May 2013Drug	CLASS II	Furosemide Injection, USP, 40 mg/ (10 mg/mL) Single-Dose Vial recalledFurosemide	Hospira	Sterility	Nationwide
6 Mar 2013Drug	CLASS II	Furosemide Injection USP (10 mg/mL) in Fliptop Vial recalled by HospiraFurosemide	Hospira	Sterility	Nationwide

Should you stop taking Furosemide?

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.