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Recall Observatory FDA recall evidence

Drug product

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

D-0489-2025

May 28, 2025

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 96947
Status
Ongoing
Classification
Class II
Quantity
98,410 vials
Official record key
drug-enforcement:D-0489-2025

Official wording

Reason: Discoloration; discolored solution from cracked vials

Code information: Lot KA5023, exp 02/28/2026

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration; discolored solution from cracked vials