D-0853-2026 Class II Ongoing

Recalled by Pfizer — Manhattan, NY

FDA drug recall D-0853-2026 was initiated by Pfizer on September 4, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
September 23, 2026
Initiation Date
September 4, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide.

Code Information

Lot # NL5230, Exp Date:10/2027