US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 16, 2013 (13 years ago)

Morphine Sulfate Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.

What was recalled

Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.

Recalling firm
Hospira, Inc.
NDC code
0409-1135-02
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-023-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Morphine recalls

See all
Class III · Low risk Ongoing

Morphine Sulfate Oral Solution 100 mg / 5 mL

Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Winder Laboratories, LLC D-0223-2026
Class II · Moderate risk Ongoing

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe

Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC D-0254-2025