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Furosemide

FDA recalls

6 rows

DateCompany and reasonClass
Mar 19, 2026Leading Pharma, LLC
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.		Class II · Ongoing
Jan 9, 2026Graviti Pharmaceuticals Private Limited
Presence of Foreign Substance		Class II · Ongoing
Dec 21, 2016Roxane Laboratories, Inc.
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.		Class II · Terminated
Sep 24, 2015Boehringer Ingelheim Roxane Inc
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.		Class III · Terminated
Feb 25, 2013Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.		Class II · Terminated
Jan 9, 2013Hospira, Inc.
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).