Class IIReported 2026-04-01

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

Recalled by Chiesi USA, Inc.

Reason for Recall

Lack of Assurance of Sterility

Recall Number

D-0402-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2026-03-17

Reported

2026-04-01

Distribution

Nationwide within the United States

Code Info

Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.