FDA Drugs recall ·
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension… recall
- Recall number
- D-0402-2026
- Date
- (initiated March 17, 2026)
- Company / brand
- Chiesi USA, Inc.
175 Regency Woods Pl Ste 600, Cary, NC, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,235 vials
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0402-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.