FDA recall D-0853-2026

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

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-09-04

Report date

2026-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Manhattan, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2026