• Posted November 26, 2025

ByHeart Formula Faces Lawsuits After Babies Sickened With Botulism

Several families have filed lawsuits against infant formula maker ByHeart, claiming its contaminated formula caused their babies to develop botulism, a rare but dangerous illness.

The legal action comes as federal investigators continue looking into the outbreak and a separate class action lawsuit continues.

So far, the U.S. Food and Drug Administration (FDA) says 31 infants in 15 states have had suspected or confirmed botulism after consuming the formula.

All of the babies were hospitalized. No deaths have been reported.

ByHeart confirmed this week that lab tests found Clostridium botulinum spores in some samples of its formula. The bacteria can release a toxin that attacks the nervous system and may lead to paralysis, breathing problems or death in severe cases.

"We immediately notified the FDA of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again," the company said.

ByHeart told NBC News that it cannot comment on the lawsuits but is "focused on the recall and root cause investigation at this time."

Families describe frightening hospital stays for their babies, many of whom needed feeding tubes and IV treatment.

In Kentucky, a woman named Hanna Everett told NBC News that her daughter Piper began showing symptoms like constipation, excessive drooling and a drooping eye after starting the formula.

"Sure enough, the can she had just finished that day was the exact lot number that was affected," Everett said.

Piper was hospitalized on Nov. 9 and given a botulism antitoxin, which had to be flown in because hospitals do not normally stock it. She has since been released.

"It feels like I let her down when I know that’s not the case. It’s hard to tell yourself that as a mother, because you’re going to blame yourself," she told NBC News. She and her husband, Michael, sued ByHeart last week for medical expenses, pain and suffering related to the contaminated formula.

Other families from Washington, Arizona and California have also filed lawsuits, describing babies who became way too weak to eat, cry or move normally before receiving treatment.

Attorney Bill Marler, who represents several families, said ByHeart has "a lot to answer for."

"If there’s a product that should be safe, it should be infant formula," he said.

Experts note that this is the first U.S. botulism outbreak ever linked to infant formula. While formula makers are not required to routinely test for Clostridium botulinum, they must follow strict cleanliness rules and are subject to FDA inspections.

In 2023, the FDA issued a warning letter to ByHeart over “significant violations” at its Pennsylvania facility. The agency cited water leaks and concerns about how the company handled possible bacterial contamination.

ByHeart said those issues have since been addressed and noted that the facility was not involved in the production of the current recalled formula.

Abigail Snyder, an associate professor of microbial food safety at Cornell University in Ithaca, New York said an FDA warning letter like ByHeart received is "pretty unusual."

Products may be made with healthy ingredients but safety of those products is a separate issue, Synder told NBC News. "Fewer ingredients and whole milk is a different attribute than microbial safety, unfortunately."

Botulism is a rare but serious illness that can cause paralysis and breathing failure in babies. Symptoms may take up to 30 days to appear and include constipation, poor feeding, loss of head control, weakness, difficulty swallowing or breathing and decreased facial expression, according to the U.S. Centers for Disease Control and Prevention.

More information

The USDA Food Safety and Inspection Service has more on clostridium botulinum & botulism.

SOURCE: NBC News, Nov. 22, 2025