Why it was recalled
Lack of Assurance of Sterility
Product description
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
Lot numbers, UPCs & expiration codes
Lot # NL5230, Exp Date:10/2027
Where it was sold
US Nationwide.
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-0853-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 4, 2026
- FDA report date
- Sep 23, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer
Original FDA data
Every field from FDA enforcement report D-0853-2026, exactly as published.
Show all FDA fields
- City
- Manhattan
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 99824
- Address
- 66 Hudson Blvd
- Code information
- Lot # NL5230, Exp Date:10/2027
- Postal code
- 10001-2189
- Report date
- Sep 23, 2026
- Product type
- Drugs
- Recall number
- D-0853-2026
- Classification
- Class II
- Recalling firm
- Pfizer
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Sep 4, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2026