FDA Drug · D-0402-2026

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

Class II · Ongoing

Lack of Assurance of Sterility

Affected lots / codes — check yours against thisLot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.

Recalling firm: Chiesi USA, Inc., Cary, NC
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 7,235 vials
Distribution: Nationwide within the United States
Recall initiated: March 17, 2026
Classified: March 20, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0402-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →