Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Furosemide recalled?

Yes — there is an active recall. 3 ongoing FDA recalls mention Furosemide (14 total). Check the affected lots below.

Most common reason: Sterility / contamination (7 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Furosemide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Furosemide recalls in 2026

2 initiated in 2026, 14 in total — newest first
Class II · Moderate risk

Furosemide Tablets

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Ongoing Nitrosamine impurity Leading Pharma, LLC NDC 69315-118-01 D-0486-2026
Class II · Moderate risk

Furosemide Tablets USP

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

Terminated Failed specification Roxane Laboratories, Inc. NDC 0054-4297-31 D-0437-2017
Class III · Low risk

FUROSEMIDE Tablets USP

CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

Terminated cGMP deviation Boehringer Ingelheim Roxane Inc NDC 0054-4299-31 D-0012-2016
Class III · Low risk

FUROSEMIDE Tablets USP

CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

Terminated cGMP deviation Boehringer Ingelheim Roxane Inc NDC 0054-4297-31 D-0011-2016
Class II · Moderate risk

Furosemide active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-695-2015
Class II · Moderate risk

Furosemide 10 Mg/Ml Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-959-2013
Class II · Moderate risk

Furosemide 50 mg/ml Injection

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Ongoing Sterility / contamination Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-730-2013
Class II · Moderate risk

Furosemide Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-367-2013
Class II · Moderate risk

Furosemide***

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1525-2012