CUROSURF Recall: Sterility Concerns with Lung Treatment

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 8, 2026.

You just welcomed a new baby, and the doctors are doing everything they can to help. You trust them implicitly. Then, you hear about a product recall in the United States – specifically for a medication intended for babies! It's unsettling, to say the least. Keep reading to find out what you need to know about this important safety alert.

• Product: CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension
• Reason for Recall: Lack of Assurance of Sterility
• Affected Units: 7,235 vials
• Affected Lot Numbers: 1213748 (Exp. Date 09/2026), 1215076 & 1215077 (Exp. Date 10/2026)
• Distribution: Nationwide within the United States

What's the Deal with This CUROSURF Recall?

Chiesi USA, Inc. has issued a voluntary product recall in the United States for CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension. This affects 7,235 vials of the medication. The reason? A "lack of assurance of sterility." Essentially, there is a concern that the product might not be completely sterile, which could pose a risk to vulnerable patients. The affected vials were sold across the U.S.

CUROSURF is a prescription medication used in newborn infants. It's administered directly into the trachea (windpipe) to help treat respiratory distress syndrome (RDS). Because it's given directly to infants, sterility is extremely important.

This is classified as a Class II recall. The FDA defines a Class II recall as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. While it's not the most severe type of recall, it's still something U.S. consumers should be aware of.

The specific lot numbers to watch out for are: 1213748 (Exp. Date 09/2026), and 1215076 and 1215077 (both Exp. Date 10/2026). These were distributed nationwide.

Why Sterility Matters

Nobody wants to find out their baby's medication isn't guaranteed sterile. Sterility is crucial for injectable medications, especially those given to infants. Non-sterile products can lead to serious infections, which can be life-threatening in newborns. That's why this issue is being taken so seriously.

The lack of assurance of sterility means that there's a possibility, however small, that the CUROSURF could contain harmful bacteria or other microorganisms. If an infant receives a contaminated dose, it could result in a serious infection, requiring intensive medical treatment.

While there's no indication that contaminated vials have reached major retailers such as Walmart, Target, Amazon, or Costco, it's still vital to be aware of the recall if your baby is being treated with CUROSURF. The medication was dispensed through hospitals and healthcare providers across the U.S.

What To Do If Your Baby Received CUROSURF

If your baby received CUROSURF, especially if they were treated in September or October of 2024 (given the expiration dates of the recalled lots), here's what you need to do immediately. Don't panic, but take these steps:

1. Contact your baby's pediatrician or the hospital where your baby was treated as soon as possible to discuss whether the CUROSURF administered was from one of the recalled lots (1213748, 1215076, or 1215077).
2. If your baby exhibits any signs of infection, such as fever, lethargy, difficulty breathing, or feeding problems, seek immediate medical attention, and tell the medical staff that your baby received CUROSURF from a recalled lot.
3. If you have a vial of CUROSURF at home (unlikely, as it's usually administered in a hospital setting), check the lot number and expiration date against the recalled lot numbers; then contact your healthcare provider for instructions on proper disposal.
4. Even if your baby seems fine, it's still wise to schedule a check-up with their pediatrician to discuss the recall and monitor for any potential delayed effects.

Chiesi USA's Responsibility

It's Chiesi USA's responsibility to ensure the safety and quality of their products. They are working to address this issue and prevent future occurrences. Based on the official recall notice, they are notifying healthcare professionals and distributors about the recall and arranging for the return of the recalled product. The company has not yet released information about previous recalls.

This CUROSURF recall highlights the stringent standards that pharmaceutical companies must adhere to, especially when it comes to products intended for vulnerable populations. It also underscores the importance of vigilant monitoring and prompt action when potential safety issues arise.

American shoppers rely on the FDA to oversee recalls like this one, and the agency confirmed that this is a voluntary recall initiated by the company. To give you a general idea, the FDA has issued about 30-40 drug recalls in the past year.

Important Product Details

Here's a detailed breakdown of the product information for this product recall in the United States. This information is important to share with your doctor or pharmacist.

• Product Name: CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension
• Dosage Form: Intratracheal Suspension
• Strength: 240 mg
• Package Size: 3L Single-dose-Vial
• NDC: 10122-510-03
• Manufacturer: Chiesi USA, Inc., Cary, NC 27518
• Lot Numbers: 1213748 (Exp. Date 09/2026), 1215076 (Exp. Date 10/2026), 1215077 (Exp. Date 10/2026)

This recall affects 7,235 vials sold across the U.S. Make sure you have this information handy when you speak with your healthcare provider.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: What is CUROSURF used for?

CUROSURF is a medication used to treat respiratory distress syndrome (RDS) in premature infants. It helps their lungs function properly.

Q: What does "lack of assurance of sterility" mean?

It means that there's a chance the product may not be completely free from bacteria or other microorganisms. This could lead to infection if administered.

Q: How do I know if my baby received a recalled lot?

Contact the hospital or healthcare provider that administered the CUROSURF to your baby. They will be able to check the lot number of the vial used against the recalled lot numbers (1213748, 1215076, and 1215077).

Q: What are the symptoms of an infection in a newborn?

Symptoms can include fever, lethargy, poor feeding, irritability, difficulty breathing, and changes in skin color. If you notice any of these, seek immediate medical attention.

Q: What is Chiesi USA doing about this recall?

Chiesi USA is notifying healthcare professionals and distributors and arranging for the return of the recalled product. They are also likely investigating the cause of the sterility issue to prevent future occurrences.