Data Foundry

Drug recalls 2013

Morphine Sulfate Injection — Class II drug recall D-023-2014

Terminated recall by Hospira, Inc., reported 2013-12-11, distributed nationwide. Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of t

Recall numberD-023-2014
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHospira, Inc., Lake Forest, IL, United States
Recall initiated2013-09-16
Classified2013-12-02
Reported by FDA2013-12-11
Terminated2014-10-28
DistributedNationwide (US)
Quantity29,700 vials
Reason classessterility, packaging
NDC00409-1135-02
Lot numbers08/13, 17368EV

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-023-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.