Curosurf Suspension
FDA Recall NDC 10122-510
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Curosurf (NDC 10122-510). A significant event, classified as Class II, was initiated on Mar 17, 2026 by Chiesi Usa, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Mar 17, 2026
Apr 01, 2026
7,235 vials
Recall Profile & Regulatory Data
Event ID
98593
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Chiesi USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Batch or Lot Expiration Information
Lot# : 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Affected Packages Involved in this Recall
10122-510-03Product
10122-510-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
