At least 51 babies have been hospitalized in a growing botulism outbreak tied to contaminated baby formula, federal health officials announced Wednesday.
The Food and Drug Administration (FDA) said suspected and confirmed cases have now been reported in 19 states among infants who consumed ByHeart formula — up from 39 cases across 18 states one week ago.
Based on the CDC’s expanded review of the cases, infants as young as 2 weeks and up to 8 months old have been falling ill since Dec. 24, 2023. No deaths have been reported.
Cases have been reported in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington and Wisconsin.
BABY FORMULA RECALLED AS INFANT BOTULISM OUTBREAK GROWS
Infant botulism is rare, typically affecting fewer than 200 babies in the U.S. each year, according to health studies. The disease is serious and can cause paralysis or death. It develops when a toxin-producing bacterium grows in the large intestine, and symptoms may take weeks to appear.
The FDA said all ByHeart formula should be absent from store shelves and noted that the product has not appeared in stores since Nov. 26.
CINNAMON POWDER RECALLED ACROSS 14 STATES OVER POTENTIAL ‘ELEVATED LEVELS OF LEAD’
“All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve ‘anywhere pack’ sticks,” the FDA said.
ByHeart released a statement on its website on Nov. 24 explaining, “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.”
“As soon as we learned from FDA of the infant botulism outbreak, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test un-opened cans of ByHeart product, and conducted a nationwide recall.”
“We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. This includes testing more product samples.”
Customers who bought ByHeart formula in retail stores can request refunds directly from the retailer, which will handle the process and provide its own refund policy details, the company said.
ByHeart did not immediately respond to FOX Business’ request for comment.
