WhichRecall
Class IIReported 2025-07-02

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

Recalled by Pfizer Inc.

Reason for Recall

Discoloration; discolored solution from cracked vials

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Recall Number
D-0489-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-05-28
Reported
2025-07-02
Distribution
Nationwide in the USA
Code Info
Lot KA5023, exp 02/28/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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