Class II Recall Issued for Poractant Alfa Over Sterility Concerns

Chiesi USA, Inc has initiated a voluntary nationwide recall of CUROSURF (poractant alfa) intratracheal suspension, 240 mg, supplied in 3 mL single-dose vials (NDC 10122-510-03). The product is indicated for intratracheal administration and is distributed by Chiesi USA, Inc, Cary, North Carolina. The recall is being conducted at the vial level. A total of 7235 vials are affected. The recall applies to lot numbers 1213748 (exp. September 2026) and 1215076 and 1215077 (exp. October 2026). The firm notified consignees via letter. The recall was initiated on March 17, 2026, and remains ongoing. Distribution occurred nationwide within the United States.

The reason for the recall is lack of assurance of sterility, a quality issue that raises the potential risk of microbial contamination in a product intended for intratracheal administration. The recall has been classified by the US Food and Drug Administration (FDA) as Class II (recall number D-0402-2026; event ID 98593), indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious outcomes. No press release has been issued. The action was voluntary and firm-initiated, and there is no termination date currently listed.

The recalling firm, Chiesi USA, Inc, Cary, North Carolina, is responsible for the action. Health care providers and pharmacies should review inventory for the affected lot numbers and follow recall instructions provided in the notification letter. CUROSURF (poractant alfa) is a pulmonary surfactant indicated for the treatment of neonatal respiratory distress syndrome (RDS) in premature infants.

Reference

FDA. Enforcement Report. April 1, 2026. Accessed April 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm