Neocate Lawsuit | 2025 Latest Updates

If you or a loved one experienced bone fractures, rickets, hypophosphatemia, skeletal deformities, or growth delays after using Neocate infant formula, you may be entitled to pursue compensation.

At Schmidt & Clark, we are dedicated to helping individuals who have suffered due to the harmful effects of Neocate formula. Our experienced legal team is here to guide you through the process and fight for the compensation you deserve.

Contact Schmidt & Clark today for a free, no-obligation consultation.

Neocate Lawsuit Overview

A recent study has linked Neocate formula to an increased risk for serious side effects including rickets, low blood phosphate levels (hypophosphatemia), and bone fractures in infants and children.

Neocate is made by Nutricia and serves as an amino acid-based formula intended for children with food and milk allergies.

The lawsuits allege that the manufacturer failed to adequately warn doctors and patients about the risk of bone fractures and other serious potential complications associated with the formula.

Latest Neocate Lawsuit Updates

March 10, 2025 – Last updated by C.L. Mike Schmidt with current information on Neocate litigation status and case evaluations.

2024 – Many individual cases may be consolidated into multidistrict litigation (MDL) due to the similar nature of claims regarding health risks from Neocate use.

2018 – The case of Robbie Elam illustrates the serious risks associated with Neocate. After suffering unexplained fractures that led to child abuse investigations, his father consulted a personal injury lawyer who presented the BONE study linking Neocate to bone fractures.

2017 – A landmark Yale study found that 94% of infants using Neocate developed serious complications including hypophosphatemia and bone fractures.

Neocate Usage Statistics and Study Findings

Medical research and market data have revealed concerning statistics about Neocate formula:

• According to a 2017 study from Yale University, 94% of 51 infants diagnosed with hypophosphatemia exclusively used Neocate products [2].
• These infants suffered from various bone disorders, including multiple fractures
• Many children showed significant improvement after switching to alternative formulas
• Neocate has been sold in the United States under multiple product names including Neocate Splash, EO28 Splash, Neocate Junior Probiotic, Neocate Junior, Neocate Nutra, Neocate Infant DHA/ARA, and Neocate Syneo Infant
• A 2018 study by the National Library of Medicine confirmed the widespread distribution of these products [1].

FDA Reports and Warnings

While there have not been official recalls of Neocate products, there have been significant warnings and alerts:

• In March 2016, Neocate’s manufacturer Nutricia issued a warning stating that babies using Neocate as a primary or sole source of nutrition “should be routinely monitored by clinicians”
• This warning is considered inadequate by legal experts as it does not mention the link between Neocate and hypophosphatemia/rickets
• The warning also fails to address the seriousness of potential complications
• The FDA has received numerous adverse event reports regarding bone problems in infants using Neocate

Neocate Injuries & Side Effects

Neocate formula has been linked to several serious health conditions that can have long-lasting effects on a child’s development and quality of life.

• Bone Fractures: Phosphorus deficiency can cause weakened bones, making them susceptible to unexplained breaks
• Hypophosphatemia: Abnormally low phosphate levels in the blood, leading to bone weakness and other systemic issues
• Rickets: A condition causing softening and weakening of bones, often with visible deformities
• Decreased Bone Mineral Metabolism: Reduced calcium and phosphorus absorption
• Osteomalacia: Softening of the bones linked to vitamin D and calcium deficiency

Less severe side effects may include headache, nausea, hair loss, skin irritation, multiple food allergies, and other physical problems.

As Neocate is a relatively popular product, families are being urged to check on their children who have been fed Neocate and, if necessary, contact a Neocate injury lawyer to pursue compensation.

An 18-month-old boy had a history of esophageal atresia/tracheoesophageal fistula repair and necrotizing enterocolitis. He was orally fed, receiving diuretics and glucocorticoids, and was relatively immobile. After 1 year of Neocate feeding, he demonstrated irritability associated with knee and skeletal manipulation. – Luisa F. Gonzalez Ballesteros from Yale University School of Medicine, Department of Pediatrics, New Haven, CT, United States

Do You Qualify for a Neocate Lawsuit?

You may qualify for a Neocate lawsuit if:

• Your child consumed Neocate formula products as a primary nutritional source
• Your child developed bone fractures, rickets, or other bone abnormalities while using Neocate
• The bone or growth issues appeared without other explanation
• Your child received medical treatment for these conditions
• You can provide medical documentation linking the injuries to Neocate use
• The symptoms improved after switching to alternative formulas

Related Article: Baby Foods Toxic Metals Lawsuit

Evidence Required for a Neocate Lawsuit

To strengthen your case, you should collect:

• Medical records documenting your child’s condition, diagnosis, and treatments
• Purchase receipts for Neocate products
• Communications with healthcare providers about your child’s symptoms
• Before and after X-rays or other imaging studies
• Growth charts showing delays or abnormalities
• Documentation of improvement after discontinuing Neocate

Damages You Can Recover

Compensation in a successful Neocate lawsuit may include:

• Medical expenses for treatments, surgeries, and ongoing care
• Physical therapy and rehabilitation costs
• Pain and suffering for your child
• Emotional distress damages for families
• Lost wages for parents caring for injured children
• Punitive damages against the manufacturer in some cases

Neocate Recall Information

To date, there have been no official recalls of Neocate products. However, in March 2016, Nutricia (the manufacturer) issued a warning stating that babies using Neocate as a primary or sole source of nutrition “should be routinely monitored by clinicians.”

This warning is considered inadequate by legal experts as it doesn’t specifically mention the link between Neocate and hypophosphatemia/rickets or address the seriousness of these complications.

Neocate Line of Brands

• Neocate Syneo Infant
• Neocate Infant DHA/ARA
• Neocate Nutra
• Neocate Junior
• Neocate Junior with Probiotics
• Neocate Splash

Related Articles:

• Baby Formula NEC Lawsuit
• Similac Infant Formula Lawsuit
• Enfamil Infant Formula Case

See all related food poisoning lawsuits our attorneys covered so far.

FAQs

1. How can parents determine if their child’s health issues are related to Neocate?

Parents can determine if their child’s health issues are related to Neocate by consulting with healthcare providers, reviewing their child’s medical history, and considering whether symptoms began or worsened after starting the formula.

2. Are there any recalls associated with Neocate?

While there may not be official recalls, parents should stay informed about any safety advisories or updates from healthcare providers and the FDA regarding Neocate. Checking for public warnings or legal actions can provide additional information.

3. What steps should I take if my child is injured by Neocate?

If your child is injured by Neocate, seek immediate medical attention, document the injury and any treatments, retain medical records and product packaging, and consult a lawyer to discuss potential legal action and compensation.

4. What if we used multiple formulas?

If you used multiple formulas it doesn’t disqualify you. Document each formula used and discuss details with your attorney to determine if Neocate was a substantial factor in your child’s condition.

5. Can I join if we switched formulas?

Yes, you can join if you switch formulas. Provide all product details to help assess your case, especially if symptoms improved after discontinuing Neocate.

6. What documentation do I need?

The documentation you need includes medical records, receipts, product packaging, and any communications with healthcare providers regarding your child’s condition and treatment.

7. How long does the legal process take?

The amount of time the process can take varies, often taking several months to years, especially if litigation or mediation is involved. Your attorney can provide a clearer estimate based on your specific case.

8. What is hypophosphatemia and how does it relate to bone fractures?

Hypophosphatemia is dangerously low levels of phosphate in the blood, which is necessary for bone growth and cellular function. This condition can lead to fragile bones, pain, and improper development in children.

9. How is rickets treated and what is the prognosis?

Rickets is typically treated with vitamin D and mineral supplements, though recovery can take months or years. In severe cases, surgery may be needed to repair bone deformities, and some complications may be permanent.

10. Has the manufacturer responded to allegations about Neocate’s safety?

The manufacturer issued a warning in 2016 stating that babies using Neocate should be monitored by clinicians, but this warning did not specifically address the risk of bone fractures or hypophosphatemia, which many legal experts consider inadequate.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for Neocate-related injuries. Most states have a statute of limitations ranging from 1-3 years from the date of injury or discovery, though special provisions may apply for cases involving children.

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP is an experienced team of trial lawyers that focus on the representation of plaintiffs in Neocate lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Our services include:

• Free, confidential case evaluations
• No upfront costs or fees
• Payment only if we win your case

If your child or other loved one sustained a bone fracture or other serious injury from Neocate, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.

References:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5884631/
2. https://www.ncbi.nlm.nih.gov/pubmed/28167344