Chies: CUROSURF 240mg Vial Recall Due to Lack of Sterility Assurance
Chiesi USA recalls CUROSURF 240mg intratracheal suspension vials due to lack of sterility assurance. Affected lots expire 09/2026 and 10/2026. Contact for remedy details.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Chiesi USA is recalling CUROSURF 240mg intratracheal suspension vials because they may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with expiration dates up to October 2026. Read more at govinfonow.com/recall/31428-chies-curosurf-240mg-vial-recall-due-to-lack-of-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/31428-chies-curosurf-240mg-vial-recall-due-to-lack-of-sterility · Updated August 17, 2026 · FDA enforcement record: FDA #D-0402-2026
Cite this page
“Chies: CUROSURF 240mg Vial Recall Due to Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31428-chies-curosurf-240mg-vial-recall-due-to-lack-of-sterility. Based on FDA recall #D-0402-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0402-2026%22&limit=1).
Why it’s dangerous
The vials may not be sterile, which could cause infections if used in medical procedures. This is a serious risk for patients receiving respiratory treatments.
Who’s affected
Healthcare professionals who use CUROSURF for respiratory treatments in patients. Those with the specific lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check the lot number on the vial: 1213748 (expires 09/2026) or 1215076/1215077 (expires 10/2026). The product is a 240mg intratracheal suspension vial for prescription use.
- Brand
Chiesi- Category
Drug
What to do — step by step
Check Vial Lot Number
Look for lot numbers 1213748 (expires 09/2026) or 1215076/1215077 (expires 10/2026) on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the product name?
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0402-2026 (March 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0402-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.