Quick Facts at a Glance
- Recall Date
- March 17, 2026
- Hazard Level
- HIGH
- Brands
- CUROSURF, Chiesi USA, Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- INFANTS, GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CUROSURF, Chiesi USA, Inc.
- Product type
- Curosurf (poractant alfa) Intratracheal Suspension 240 mg, 3L Single-Dose Vial
- Model numbers
- Lot #: 1213748, Exp. Date 09/2026, 1215076, 1215077, Exp. Date 10/26.
- UPC codes
- 10122-510, 10122-510-03, 10122-510-01
- Sizes
- 3L
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 17, 2026
Reported by FDA DRUG
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Chiesi USA, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Curosurf is a neonatal surfactant used to treat respiratory distress in preterm infants. It is delivered intratracheally in a hospital setting.
Why This Is Dangerous
Lack of sterility could introduce microbial contamination, potentially causing infection in vulnerable neonates.
Industry Context
This recall is not indicated as part of a broader industry pattern at this time.
Real-World Impact
Hospitals must halt use of affected vials and coordinate with distributors for replacement; potential patient risk if contaminated product is administered.
Practical Guidance
How to identify if yours is affected
- Verify NDC 10122-510-03 on the product label.
- Check lot numbers 1213748, 1215076, 1215077.
- Confirm expiration dates 09/2026 or 10/2026.
Where to find product info
NDC and lot numbers are printed on vial labels and packaging.
What timeline to expect
Replacements or credits are typically coordinated within hospital supply chains over several weeks; patient care adjustments may occur during this时间.
If the manufacturer is unresponsive
- Escalate to hospital procurement leadership
- Contact Chiesi USA’s recall notice for escalation procedures
- File a report with the hospital's CPS/CQA department
How to prevent similar issues
- Source neonatal surfactants only through approved hospital distributors
- Verify sterility and batch information before administration
- Maintain updated recall contact lists for suppliers
Documentation advice
Keep a copy of the recall notice, purchase records, lot numbers, and all correspondences with the supplier.
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Product Details
Product: Curosurf (poractant alfa) Intratracheal Suspension, 240 mg, 3L Single-Dose Vial, Rx only. NDC: 10122-510-03. Distributed nationwide to healthcare facilities. Quantity recalled: 7,235 vials. Lot numbers: 1213748, 1215076, 1215077. Expiration dates observed: 09/2026 and 10/2026. Sold by: Nationwide healthcare distribution. Manufacturer: Chiesi USA, Inc., Cary, NC.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Exp. dates 09/2026 and 10/2026
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Safety Guide
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