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; improperly crimped fliptop...

Date: December 3, 2014
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, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

Quantity: 62,650 vials

Why Was This Recalled?

Lack of Assurance of Sterility; improperly crimped fliptop vials

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.

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