Recalls / Class II
Class IID-0489-2025
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
- Brand name
- Dobutamine
- Generic name
- Dobutamine
- Active ingredient
- Dobutamine Hydrochloride
- Route
- Intravenous
- NDC
- 0409-2344
- FDA application
- ANDA074086
- Affected lot / code info
- Lot KA5023, exp 02/28/2026
Why it was recalled
Discoloration; discolored solution from cracked vials
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 98,410 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-05-28
- FDA classified
- 2025-06-23
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0489-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.