AUSTIN, (KXAN) – The U.S. Food and Drug Administration issued a warning about homemade infant formula after reports of babies being hospitalized. 

An FDA spokesperson said the agency recently received reports of infants suffering from hypocalcemia in Delaware after being fed homemade formula. The condition is rare and means there is low calcium in the blood. 

“This is the first public health alert the FDA has issued about homemade infant formula. However, since 2006, the FDA has stated that the agency does not recommend that consumers make infant formulas at home because of potentially very serious health concerns,” said the FDA spokesperson.

Infant formula, in liquid and powder forms, is strictly regulated by the FDA.

“The agency has requirements for certain nutrients in infant formulas, and if the formula does not contain these nutrients at or above the minimum level or within the specified range, the infant formula is adulterated,” said the FDA alert

Homemade infant formula not regulated

The agency explained that homemade infant formula recipes have not been evaluated and may lack nutrients vital to an infant’s growth.

Recipes for homemade infant formulas found online include everything from raw whole milk to egg yolks.  

“It is not safe,” Dr. Lisa Gaw, a pediatrician with Texas Children’s Urgent Care in Austin explained. “There’s contamination leading to infection and illness risk and then there is a risk that your child may not be getting everything that he or she needs.”

Dr. Gaw said babies should either be fed breastmilk or FDA-approved formulas. 

“When they are this young their bodies are still developing and the way they process things are a little different than say a one-year-old toddler,” Dr. Gaw explained. “Too little or too much of any nutrient, whether it’s vitamin or mineral, can be harmful to an infant in the age group. They’re still developing.”

Impact of hypocalcemia

The Texas Department of State Health Services said it hasn’t received any similar reports. A spokesperson explained that hypocalcemia is not a condition that’s required to be reported to public health. 

The FDA said symptoms of hypocalcemia in infants include: 

  • Seizures
  • General and/or neuromuscular irritability (jitteriness, tremors)
  • vomiting, poor feeding
  • Lethargy

The agency spokesperson also explained that symptoms can lead to heart problems and other foodborne illnesses that can be life-threatening. 

According to the FDA, parents or caregivers of infants who have been fed homemade infant formula should contact their pediatricians and report any symptoms.

More families needing baby formula 

The agency wouldn’t elaborate on why the babies were fed homemade formulas, but explained that there is no shortage of formula across the country.

The Austin Diaper Bank has seen an increase in families over the last year needing diapers and baby formula. (Courtesy: Holly McDaniel)

Nonprofit organizations like the Austin Diaper Bank have seen a spike in families needing baby formula and diapers over the last year.  

“We’ve seen a 25% increase just especially in the last few weeks because of the winter storms,” Holly McDaniel, Executive Director, Austin Diaper Bank said. “Families were without water, there were a lot of issues of getting to the store, and also we’re just seeing poverty rates increase because of the pandemic and loss of income and jobs and formula can be really expensive.”

McDaniel said they have strict rules about accepting infant formula donations and don’t take anything that’s open or expired. 

“We accept unopened FDA-approved formula from the manufacturers that’s at least two months outside of its expiration date. We also collect and distribute formula from our manufacturing partners, so we know it’s safe before it goes out the door to families in our community,” McDaniel explained.

For parents needing formula, McDaniel said to start online and connect with the more than 30 local agencies they partner with to provide diapers and formula.

Families can also call United Way’s Helpline by dialing 2-1-1 or by going to