Pfizer Inc.: Drug Recall
Recall #D-0489-2025 · 05/28/2025
Class II: Risk
Recall Details
- Recall Number
- D-0489-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Pfizer Inc.
- Status
- Ongoing
- Date Initiated
- 05/28/2025
- Location
- New York, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,410 vials
Reason for Recall
Discoloration; discolored solution from cracked vials
Product Description
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
Distribution Pattern
Nationwide in the USA
Other Recalls by Pfizer Inc.
- Class II: Risk 08/04/2025
- Class II: Risk 08/04/2025
- Class II: Risk 07/10/2025
- Class II: Risk 07/10/2025
- Class II: Risk 05/20/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.