Recall: D-0402-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-17Initiated

OngoingStatus

Chiesi USA, Inc.Firm

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

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.