Parents start their babies on the hypoallergenic infant formula Neocate in hopes that it will alleviate digestive upsets while delivering full nutrition to their developing children. A few minor Neocate side effects could reasonably be expected as the baby’s digestive system adapts to the new formula.


However, there have been adverse reports of bone fractures and rickets in young children taking Neocate, which is an unacceptable risk that should be included on the warning label.


If your child suffered adverse side effects of Neocate, talk to your pediatrician about weaning off the formula and switching to a different type. Next, call Showard Law Firm to find out if you have a case for compensation through the civil courts. You may be entitled to money damages to cover medical bills, lost time off work spent caring for your injured child, and more. The statute of limitations in your state restricts the amount of time you have to file a lawsuit, so please contact our firm today for a free consultation.


Most Common Neocate Side Effects

After switching to a new formula to treat food allergies, digestive changes typically take place within the first few days and persist up to two weeks. According to the manufacturer, common Neocate side effects include:


  • A change in bowel movement color (typically yellow, green, or khaki)
  • Decreased frequency in bowel movements (sometimes as low as one every day or two)
  • A change in stool consistency (loose or more formed, depending on the child)
  • Increased flatulence or a change in odor, along with temporary discomfort and fussiness (two weeks)


Many of these mild changes are not unlike what you’d see when first introducing solids to a baby’s diet.


Neocate Long Term Effects May Include Bone Fractures and Rickets


Over time, more serious Neocate long term effects have been reported, such as:


  • Hypophosphatemia (HPP) – An April 2017 study published in the journal Bone uncovered a strong connection between Neocate and the development of Rathbun Disease, also called hypophosphatemia or HPP. Abnormal tooth and bone development occurs due to defective mineralization processes. The bones become soft and weak. Typically, the disease involves a rare inherited gene mutation, but new links have suggested children can develop HPP after prolonged periods of nutrient deficiency.


  • Bone Fractures – Children with bone fractures will likely cry incessantly, refuse to put weight on the affected limb, and complain of pain. Sometimes the region may swell or discolor to black-and-blue, but not always. Complex fractures show obvious deformity. The Clarion-Ledger told the story of a father who was accused of child abuse when his son sustained multiple, unexplained fractures. When faced with Child Protective Services taking his child out of his custody, the man hired an attorney and discovered that the fractures could have been due to his son’s use of the Neocate formula. The child spent five months in the hospital weaning off the formula, but ultimately recovered and was remanded back to his father’s care.


  • Rickets – A skeletal disorder may result from insufficient vitamin D, calcium, or phosphate. Children with the disorder may have soft, weak bones; stunted growth and development; or a noticeable deformity. The first symptoms may include: pain or tenderness in the arms, legs, pelvis, or spine; failure to reach growth milestones; bone fractures; muscle cramps; delayed tooth formation; bow legs; large forehead; curved spine; wide joints; or an enlarged A 2017 study published in Bone Abstracts called Neocate “a rare cause of rickets.”


Problems With Neocate Formula Were Known to Manufacturers Nutricia and Danone


Problems with Neocate should have been apparent since 2002 when phosphorus was well-established as a “codependent” factor (along with calcium) in bone development. Lawsuits allege that the manufacturers of Neocate failed to research and develop a safe product before putting it on the market.


By 2017, there was no doubt of the connection between infants with HPP or broken bones and Neocate. In the aforementioned Bone journal study, 51 children with unexplained HPP, fractures, under-mineralization, or rickets were observed in 94% of cases. Most children had been solely fed Neocate for variable periods of time prior to presentation, and nearly all children recovered after treatment with supplemental phosphate or a different formula product. “The widespread nature of the findings lead us to strongly recommend careful monitoring of mineral metabolism in children fed elemental formula,” the authors wrote.


Between 2015 and 2018, the manufacturer had its own panel of experts investigating the correlation. Nutricia subsequently changed the formula to include a more soluble form of phosphate that is more readily processed and absorbed through the digestive process. However, the damage had already been done for infants taking earlier products like Neocate Syneo Infant, Neocate Infant DHA/ARA, Neocate Nutra, Neocate Junior, Neocate Junior with Probiotics, or Neocate Splash.


What to Do About Neocate Formula Side Effects


If your child has suffered from Neocate formula side effects:


  • See an emergency medical provider for broken bone treatment. Urgent care or orthopedic specialists will likely put your child in a temporary “air cast” until the swelling goes down in 1-2 days. From there, a harder fiberglass cast will be placed over the broken bone for approximately three weeks. It typically takes another month for children to begin moving normally again after the cast comes off, but some children may require physical therapy.
  • Consider supplementation. Most pediatricians will recommend Vitamin D and Calcium supplementation for rickets treatment or bone fracture recovery. Often, physicians recommend supplementation for any infant who is not receiving breastmilk for primary nutrition.  
  • Ask your pediatrician about weaning and Neocate alternatives. Researchers in the Bone journal study advised gradually weaning a child off a medical food or supplement under a doctor’s supervision to avoid hypocalcemia. One father compared the side effects of weaning his son off Neocate to “withdrawing from some illegal drug.” There are many cow’s milk alternatives to consider – including soy, oat milk, hydrolyzed casein or whey, or alternate amino acid formula Nutramigen.
  • Contact a personal injury attorney. Children typically fully recover from bone fractures and rickets over time. However, you may be eligible to receive compensation to cover your financial investment in the product, related medical expenses, lost wages from time taken off work to care for your injured child, and an estimated amount for “pain and suffering.”


It is simply unacceptable for infant formula manufacturers to create substandard products that put our children at risk for harm and to fail to warn the public of product defects. At Showard Law Firm, it’s our job to fight with you shoulder to shoulder to make sure they don’t get away with it.


If you have questions about filing a Neocate lawsuit, contact us for a free consultation. We charge you nothing upfront for our services, and we collect no fees unless we recover on your behalf.


Additional resources: