Poractant Alfa Recall: Curosurf 240 mg 3L Single-dose-Vial
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. |
|---|---|
| Lot / date codes | Lot #: 1239521, 1237454, Exp. Date 10/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.