Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot KA5023, exp 02/28/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0489-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 28, 2025
- FDA report date
- Jul 2, 2025
- Quantity
- 98,410 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0489-2025, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 96947
- Address
- 235 East 42nd Street
- Code information
- Lot KA5023, exp 02/28/2026
- Postal code
- 10017-5703
- Report date
- Jul 2, 2025
- Product type
- Drugs
- Recall number
- D-0489-2025
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 98,410 vials
- Reason for recall
- Discoloration; discolored solution from cracked vials
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- May 28, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2025