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.

Morphine Sulfate Injection Recalled by Fresenius Kabi USA LLC Due to Defective container: Cracked vials leading to lack of...

Date: September 17, 2021
Company: Fresenius Kabi USA LLC
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 Fresenius Kabi USA LLC directly.

Affected Products

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

Quantity: 963000 vials

Why Was This Recalled?

Defective container: Cracked vials leading to lack of sterility assurance

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Kabi USA LLC

Fresenius Kabi USA LLC has 3 total recalls tracked by RecallDetector.

Related Recalls

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