Recalling firm
Pfizer Inc.
Product type
Drug
Status
Ongoing
Report date
2025-07-02
Distribution
Nationwide in the USA
Firm state
NY
Product quantity
98,410 vials
Initiated by
Voluntary: Firm initiated
Reason for recall
Discoloration; discolored solution from cracked vials
Product description
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
Code / lot info
Lot KA5023, exp 02/28/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.