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,…

Recall date

May 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0489-2025

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Discoloration; discolored solution from cracked vials

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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