Pfizer Inc. recalls DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, F
Recalled July 2, 2025 · FDA recall D-0489-2025 · Pfizer
Hazard
Discoloration; discolored solution from cracked vials · FDA Class II
Units
98,410 vials
Sold at
Nationwide in the USA
Description
Discoloration; discolored solution from cracked vials
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
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →