Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fentanyl Citrate Injection Recalled by Hospira Inc. Due to Lack of Assurance of Sterility: Complaints of broken...

Date: November 1, 2016
Company: Hospira Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hospira Inc. directly.

Affected Products

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Quantity: 797,800 ampules

Why Was This Recalled?

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hospira Inc.

Hospira Inc. has 245 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report