Agency classClass IIOur severity:Severe FDA (Drugs)·D-169-2013·Announced 2013-03-06

Hospira Recalls Furosemide Injection Vials Due to Sterility Concerns

Hospira is recalling 63,900 vials of Furosemide Injection USP because a loose crimp on the vial cap may compromise sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for potential serious, reversible health consequences.

Plain-English summary

Hospira, Inc. is recalling 63,900 vials of Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, NDC 0409-6102-04. The recall was initiated due to a lack of assurance of sterility, which may be caused by a possible loose crimp applied to the fliptop vial.

The affected product is a prescription-only medication intended for intramuscular or intravenous administration. The recall covers product distributed nationwide. The specific lot code associated with this recall is 18-099-DK.

Healthcare providers and patients should check their inventory for the specific NDC and lot code listed above. If the product is found, it should be quarantined and not administered until further notice. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or replacement products.

The recalled product

Product: FUROSEMIDE (FUROSEMIDE)
Brand: FUROSEMIDE
Manufacturer: Hospira, Inc.
Category: Drug — Injection
Hazard: sterility
infection
Affected units: 63,900

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

18-099-DK

Distribution

Distributed nationwide across the United States.

Same brand · FUROSEMIDE

Moderate
Furosemide tablets recalled for presence of N-nitroso impurity
FDA (Drugs) · 2026-04-29
High
Furosemide tablets recalled over the presence of a foreign substance
FDA (Drugs) · 2026-01-28
Moderate
Roxane Recalls Furosemide Tablets Due to Unusually Thick Tablet Report
FDA (Drugs) · 2017-02-01
Moderate
Boehringer Ingelheim Roxane Recalls Furosemide Tablets Due to Manufacturing Error
FDA (Drugs) · 2015-10-21
Moderate
Boehringer Ingelheim Roxane Recalls Furosemide Tablets Due to CGMP Deviations
FDA (Drugs) · 2015-10-21

Same manufacturer · Hospira, Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16

Same hazard · sterility