Chies: CUROSURF 240mg Vial Recall Due to Lack of Sterility Assurance

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Recalling firmChiesi USA, Inc.175 Regency Woods Pl Ste 600 · Cary, NC 27518-6007

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

What is the product name?

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only.

What lot numbers are affected?

Lot numbers 1213748 (expires 09/2026) and 1215076, 1215077 (expires 10/2026).

How can I check if I have the recalled product?

Check the lot number on the vial: 1213748 (expires 09/2026) or 1215076/1215077 (expires 10/2026).

Take action

Contact Chiesi

We’ve drafted a message you can send Chiesi to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0402-2026 — Chiesi Chiesi

Hello,

I own a Chiesi that is covered by recall D-0402-2026 from Chiesi.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Chiesi USA, Inc. recalls CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC

Recall notice