Poractant Alfa Recall: Curosurf 240 mg 3L Single-dose-Vial
Announced 2026-07-22 · FDA
Curosurf (poractant alfa) intratracheal suspension in 3L single-dose vials is recalled due to lack of assurance of sterility. About 7,235 vials distributed nationwide in the United States are included in the recall, covering Lot 1213748 (exp. 09/2026) and Lot 1215076 and 1215077 (exp. 10/26). The recall is being conducted by Chiesi USA, Inc.
| Brand | 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 |
| Severity | moderate |
| Units affected | 44280 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. |
WHAT YOU SHOULD DO
- Do not use any Curosurf vials matching Lot 1213748 (exp 09/2026) or Lot 1215076/1215077 (exp 10/26).
- Check your inventory to identify any affected vials and set them aside from use.
- Contact your healthcare provider, hospital pharmacy, or Chiesi USA for guidance on replacement or disposal.
- Follow all FDA and supplier instructions for returning, disposing of, or replacing the recalled product.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.