Recall Weekly← all recalls
FDA-Drug2026-04-01Class IIPROCESSING DEFECT

Chiesi CUROSURF (poractant alfa) recalled for lack of sterility assurance

Chiesi
OTHERNationwide distribution

Stop using recalled CUROSURF lung surfactant

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.
Hazard

Lack of Assurance of Sterility

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-0402-2026

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief