MINNEAPOLIS, Nov. 12, 2025 /PRNewswire/ — OFT Food Safety & Injury Lawyers have filed the first lawsuit arising from a multistate Infant Botulism outbreak linked to infant formula manufactured by ByHeart, Inc. The Plaintiffs Hanna and Michael Everett allege that ByHeart Whole Nutrition formula was contaminated and caused their infant daughter’s infant botulism. The lawsuit has been filed in United States District Court for the Eastern District of Kentucky, Case No. 5:25-cv-00422. A copy of the Complaint is available upon request.
The CDC has identified at least 15 cases of infant botulism following consumption of ByHeart Whole Nutrition formula. The California Department of Public Health tested a can of ByHeart formula linked to a case and this testing showed the presence of bacteria that produce botulinum toxin. The company initially recalled just two lots of formula, but has since expanded the recall to all formula products.
The Plaintiffs are the parents of a four-month old baby girl who consumed ByHeart formula and subsequently developed infant botulism, a condition caused by ingesting spores of the Clostridium botulinum bacteria. The botulinum toxin causes weakness and loss of muscle tone which can lead to respiratory distress and other dangerous complications.
Infants are particularly vulnerable to contaminants in formula because their immune and gastrointestinal systems are still developing, according to food safety attorney Brendan Flaherty. “We know that infants are vulnerable to any contamination in formula,” Flaherty said. “That is why safety – not profit – must be the first priority for any formula manufacturer. The bacteria that produce botulinum toxin should never be in formula because that toxin can kill your baby if not diagnosed and treated.”
Flaherty pointed out that ByHeart recalled five batches of formula in 2022 following contamination with another dangerous pathogen, Chronobacter sakazakii. The FDA subsequently issued the company a Warning Letter outlining safety issues in the production process.
“Our clients want answers and just as important, want to make sure that this never happens to another family,” Flaherty said.
The lawsuit alleges that ByHeart’s marketing materials were misleading and that the company’s response to the 2022 contamination inadequate.
With over 4 decades of experience, the lawyers at OFT Food Safety & Injury Lawyers have recovered millions on behalf of food poisoning victims. OFT is one of the largest national law firms committed to representing food poisoning victims. If you have been affected by this outbreak, contact OFT Law for a free consultation today. Call or text 888-828-7087 or email [email protected].
SOURCE OFT Law PLLC
