FDA-Drug2026-04-01Class IIPROCESSING DEFECT
Chiesi CUROSURF (poractant alfa) recalled for lack of sterility assurance
What this means
Chiesi USA is recalling specific lots of CUROSURF, a medication given to premature infants to help them breathe. The company cannot confirm that all vials are sterile, which means they may be contaminated. No infections have been reported so far.
- If you have CUROSURF with lot #1213748 (expires 09/2026) or lot #1215076 or #1215077 (expires 10/2026), do not use it.
- Contact your hospital or healthcare provider immediately if you have these lots.
- Ask your provider about safe alternative medications.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Infants (under 12 months)
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
7,235 vials
Manufactured in
175 Regency Woods Pl Ste 600, Cary, NC, United States
Products
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2026More Chiesi recalls
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