Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
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.
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Presence of Foreign Substance
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Lack of Assurance of Sterility
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.
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.
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.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
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.
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