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Prescription medicine

Poractant alfa

Brand names: Curosurf

Drug class: Surfactant

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
1Companies
1999First FDA approval on file

Quick answers

What is Poractant alfa used for?
The FDA-approved label (Curosurf, Chiesi USA, Inc., December 10, 2025) says: “CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Poractant alfa have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Poractant alfa?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Poractant alfa been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started March 17, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Poractant alfa?
1 company lists prescription products of Poractant alfa in the FDA NDC Directory, including Chiesi USA, Inc..

What Poractant alfa is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants.

— FDA label: Curosurf, Chiesi USA, Inc., effective December 10, 2025. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsSuspension
RouteEndotracheal
Prescription products1 in the FDA NDC Directory
Brand namesCurosurf

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA020744
CUROSURF		 Chiesi USA IncNovember 18, 1999 19, latest May 17, 2021
2021: Labeling · 2019: Labeling · 2016: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. March 17, 2026 · Class II · Ongoing · D-0402-2026

    Lack of Assurance of Sterility

    CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Chiesi USA, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)259216, 261329
SPL set ID of the quoted label99bef307-00bd-4379-9f45-ede1380e74d4
FDA labels (SPL)1
FDA applicationsBLA020744
Active ingredients (FDA)PORACTANT ALFA

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Curosurf, Chiesi USA, Inc., effective December 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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