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

Lack of Assurance of Sterility

Class II Medicine & devices FDA April 1, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Chiesi USA, Inc. — Cary, NC
Severity
Class II — moderate
Reported
April 1, 2026
Quantity
7,235 vials
Recall number
D-0402-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the United States

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