FDA recall D-0402-2026

Chiesi USA, Inc. · Class II · drug

Product

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2026-03-17
Report date: 2026-04-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cary, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2026