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: 04

FDA recall notice · announced July 2, 2025 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Discoloration; discolored solution from cracked vials

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot KA5023, exp 02/28/2026
Quantity: 98,410 vials
Status: Ongoing
Products in this recall event:
- 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 Fores (D-0489-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.