Pfizer recalls Dopamine HCl Inj., USP, 200 mg/5 mL vials over lack of assurance of sterility
The notice says there is a lack of assurance of sterility for these 5 mL single-dose vials of Dopamine HCl Inj., USP, which were distributed nationwide in the US by Hospira, Inc.
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- Product
- 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.
- Company
- Pfizer
- Hazard
- Lack of Assurance of Sterility
- Units
- N/A
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- September 17, 2026
- Recall started
- September 4, 2026
- FDA enforcement report
- September 23, 2026
- Identifiers
- Codes: Lot # NL5230, Exp Date:10/2027
- FDA recall number: D-0853-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Reason for recall
- Lack of Assurance of Sterility
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- N/A
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