Agency classClass IIOur severity:Severe FDA (Drugs)·D-314-2013·Announced 2013-05-15

Hospira Recalls Furosemide Injection Vials Due to Sterility Concerns

Hospira Inc. is recalling 259,050 vials of Furosemide Injection due to a loose crimp on the vial cap that compromises sterility assurance.

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 source text identifies a 'Lack of Assurance of Sterility' for an injectable drug, which poses a significant risk of serious injury or death from infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Hospira Inc. is recalling 259,050 vials of Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial. The recall is being conducted because a loose crimp was applied to the fliptop vial, which results in a lack of assurance of sterility.

The affected product is identified by Lot 20-564-DK with an expiration date of 02/14. The product was distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class II.

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the manufacturer for further instructions. Consumers should not use the product if they have questions regarding its sterility.

The recalled product

Product: FUROSEMIDE (FUROSEMIDE)
Brand: FUROSEMIDE
Manufacturer: Hospira Inc.
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 259,050

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)

Lot 20-564-DK Exp. 02/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same brand · FUROSEMIDE

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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 Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16

Same hazard · sterility