CUROSURF recall (Chiesi USA, Inc.)
DrugClass IIOngoing
Summary: Chiesi USA, Inc. is recalling 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.
What is being recalled
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Why
Lack of Assurance of Sterility
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0402-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 17, 2026 |
| Reported | April 1, 2026 |
| Company | Chiesi USA, Inc. |
| Company location | Cary, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7,235 vials |
More recalls from Chiesi USA, Inc. · all drug recalls · recalls from March 2026