CUROSURF recalled over sterility concerns
- Recall date
- March 17, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Chiesi USA, Inc. recalls CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27…
- Recall number
- D-0402-2026
- FDA classification
- Class II
- Brand / firm
- Chiesi USA, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
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