CUROSURF Sterility Recall - Chiesi USA
Summary
FDA announced Class II recall D-0402-2026 for CUROSURF (poractant alfa) 240mg Intratracheal Suspension by Chiesi USA, Inc. The recall was initiated due to lack of assurance of sterility. The affected product (NDC 10122-510-03) was distributed nationwide within the United States, and the recall is currently ongoing.
What changed
Chiesi USA, Inc. initiated a Class II drug recall for CUROSURF (poractant alfa) 240mg Intratracheal Suspension (NDC 10122-510-03, 3L Single-dose-Vial) due to lack of assurance of sterility. The product was manufactured in Cary, NC and distributed nationwide throughout the United States. Recall identification number is D-0402-2026 with effective date April 1, 2026.
Healthcare providers and pharmaceutical distributors should immediately verify whether they have any units of the affected product (NDC 10122-510-03) in stock. Any affected product should be quarantined and not administered to patients. Report any adverse events potentially associated with sterility concerns to FDA MedWatch. Pharmacies and clinical facilities should check their inventory systems and return procedures.
What to do next
- Verify inventory for CUROSURF (poractant alfa) 240mg with NDC 10122-510-03
- Quarantine and cease administration of any affected product in stock
- Report adverse events potentially related to sterility concerns to FDA MedWatch
Source document (simplified)
Chiesi USA, Inc.
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0402-2026 · 20260401 · Ongoing
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
Source: openFDA Enforcement API
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