FDA Drug recall D-0402-2026
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03
- FDA Drug
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03 by Chiesi Usa, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0402-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-17 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Chiesi Usa |
| Distribution | US |
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
Identifiers
| ndc | 10122-510-03 |
|---|---|
| ndc | 10122-510-01 |
| code_info | Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0402-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.