FDA Drug · D-0489-2025

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

Class II · Ongoing

Discoloration; discolored solution from cracked vials

Affected lots / codes — check yours against thisLot KA5023, exp 02/28/2026

Recalling firm: Pfizer Inc., New York, NY
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 98,410 vials
Distribution: Nationwide in the USA
Recall initiated: May 28, 2025
Classified: June 23, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0489-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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