Warning
Chiesi USA Recalls CUROSURF (poractant alfa)
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0402-2026Drug / Pharmaceutical
Chiesi USA Recalls CUROSURF (poractant alfa)
Chiesi USA, Inc. · Class II — Moderate Risk
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.
Reason for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Chiesi USA, Inc. has recalled a pharmaceutical product that the FDA classified as Class II affecting 7,235 vials. The recall was initiated on March 17, 2026. Lack of Assurance of Sterility. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.