FDAFDA · Food and drugs·Recall number D-0489-2025
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
Published July 2, 2025 · Recall initiated: May 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration; discolored solution from cracked vials
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DOBUTAMINE
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot KA5023, exp 02/28/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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