FDAFDA · Food and drugs·Recall number 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.
Published April 1, 2026 · Recall initiated: March 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CUROSURF
- Manufacturer
- Chiesi USA, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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