FDA Recall D-0402-2026

Chiesi USA, Inc. · Cary, NC

Class II Ongoing 58 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: 7,235 vials

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0402-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2026-03-17
Classified by FDA Center: 2026-03-20
FDA published: 2026-04-01
Recalling firm: Chiesi USA, Inc.
Firm location: Cary, NC

Drug identification

Brand name(s): CUROSURF
Generic name(s): PORACTANT ALFA
Manufacturer(s): Chiesi USA, Inc.
NDC(s): 10122-510
Route(s): ENDOTRACHEAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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