Chiesi Curosurf Recall: FDA Class II

Why it was recalled

Lack of Assurance of Sterility

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.

Where it was sold

Nationwide within the United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0402-2026
Classification: Class II
Status: Ongoing
Recall initiated: Mar 17, 2026
FDA report date: Apr 1, 2026
Quantity: 7,235 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Chiesi USA, Inc.

Original FDA data

Every field from FDA enforcement report D-0402-2026, exactly as published.

Show all FDA fields

City: Cary
State: NC
Status: Ongoing
Country: United States
Event ID: 98593
Address: 175 Regency Woods Pl Ste 600
Code information: Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Postal code: 27518-6007
Report date: Apr 1, 2026
Product type: Drugs
Recall number: D-0402-2026
Classification: Class II
Recalling firm: Chiesi USA, Inc.
Product quantity: 7,235 vials
Reason for recall: Lack of Assurance of Sterility
Voluntary / mandated: Voluntary: Firm initiated
Product description: CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Distribution pattern: Nationwide within the United States
Recall initiation date: Mar 17, 2026
Initial firm notification: Letter
Center classification date: Mar 20, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0402-2026, published Apr 1, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Chiesi Curosurf Recall

Summary