CUROSURF — Class II drug recall D-0402-2026
Ongoing recall by Chiesi USA, Inc., reported 2026-04-01, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0402-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chiesi USA, Inc., Cary, NC, United States |
| Recall initiated | 2026-03-17 |
| Classified | 2026-03-20 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 7,235 vials |
| Reason classes | sterility |
| NDC | 10122-0510, 10122-0510-01, 10122-0510-03 |
| Lot numbers | 10/26, 1213748, 1215076, 1215077 |
| Expiration dates | 2026-09 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0402-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.