Class II · ModerateActive recall
Curosurf
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byChiesi USA, Inc.
| Brand name | CUROSURF |
| Generic name | PORACTANT ALFA |
| Active ingredient(s) | PORACTANT ALFA |
| Distributed by / for | Chiesi USA, Inc. |
| NDC | 10122-510-03 |
Show the full FDA record
| Full product label | CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. |
| Recalling firm | Chiesi USA, Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 7,235 vials |
| Recall initiated | 2026-03-17 |
| Report date | 2026-04-01 |
| Recall completed | — |
| Recall number | D-0402-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Cary NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.