FDA Drugs recall ·
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL)… recall
- Recall number
- D-0489-2025
- Date
- (initiated May 28, 2025)
- Company / brand
- Pfizer Inc.
235 East 42nd Street, New York, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 98,410 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Discoloration; discolored solution from cracked vials
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot KA5023, exp 02/28/2026
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0489-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.