Furosemide

Furosemide recalls: 7 FDA reports

Recalls involving Furosemide. What was wrong with each batch, and how the FDA graded the risk.

7Reports
0Class I
2Ongoing
2026-04-29Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II5
Class III2

By year reported

YearReports
20132
20152
20171
20262
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield,

D-0486-2026  ·  Class II  ·  reported 2026-04-29  ·  Ongoing

Why it was recalled
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Product
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Where it went
US Nationwide.
How much
9384 bottles

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Bru

D-0293-2026  ·  Class II  ·  reported 2026-01-28  ·  Ongoing

Why it was recalled
Presence of Foreign Substance
Product
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Where it went
U.S. Nationwide
How much
4212 bottles

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216,

D-0437-2017  ·  Class II  ·  reported 2017-02-01  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Product
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Where it went
Nationwide in the USA
How much
6493 bottles

FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane La

D-0011-2016  ·  Class III  ·  reported 2015-10-21  ·  Terminated

Why it was recalled
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.
Product
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Where it went
Nationwide and Puerto Rico
How much
11,110 bottles

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

D-0012-2016  ·  Class III  ·  reported 2015-10-21  ·  Terminated

Why it was recalled
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.
Product
FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
Where it went
Nationwide and Puerto Rico
How much
5,160 bottles

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL

D-314-2013  ·  Class II  ·  reported 2013-05-15  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
Where it went
Nationwide and Puerto Rico
How much
259,050 vials

Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC

D-169-2013  ·  Class II  ·  reported 2013-03-06  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Product
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Where it went
Nationwide
How much
63,900 vials
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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