Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Leading Pharma, LLC

NDC code

69315-118-01

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0486-2026

Other Furosemide recalls

See all

Class II · Moderate risk Ongoing Jan 10, 2026

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816…

Reason Presence of Foreign Substance

Graviti Pharmaceuticals Private Limited NDC 64980-563-10 D-0293-2026

Class I · High risk Terminated Aug 27, 2018

Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals…

Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.

SCA Pharmaceuticals, Inc. D-1189-2018

Class II · Moderate risk Terminated Dec 22, 2016

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

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

Roxane Laboratories, Inc. NDC 0054-4297-31 D-0437-2017

Class II · Moderate risk Terminated Oct 19, 2015

Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Reason Lack of Assurance of Sterility

Western Drug D-0405-2016

Class III · Low risk Terminated Sep 25, 2015

FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc…

Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture…

Boehringer Ingelheim Roxane Inc NDC 0054-4299-31 D-0012-2016