Reported Apr 1, 2026 · Ongoing

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC…

Chiesi USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Chiesi USA, Inc. · 175 Regency Woods Pl Ste 600 · Cary, NC · 27518-6007

Is this the product you have?

  • CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lot codes and dates
    • Lot #: 1213748
    • Exp. Date 09/2026
    • 1215076
    • 1215077
    • Exp. Date 10/26
Amount recalled
7,235 vials

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 3:22 PM UTC

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