Chiesi USA, Inc. recalls CUROSURF
- Recalling company
- Chiesi USA, Inc.
- Product
- CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 17, 2026
- Reported
- Apr 1, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 7,235 vials
- Lot / codes
- Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
- Company location
- Cary, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0402-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0402-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.