The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is
November 14, 2025
Today, US Representative Rosa DeLauro released a letter she wrote to FDA Commissioner Marty Makary requesting the Food and Drug Administration facility inspection records for ByHeart, following reporting that the company’s infant formula was linked to an infant botulism outbreak:
“There must never be a question in parents’ minds that
Parents and guardians should immediately stop using ByHeart Whole Nutrition Infant Formula.
This additional case has not yet been added to CDC numbers.
A Pierce County infant was diagnosed Nov. 13, 2025, with suspected infant botulism. The infant is being treated at a local hospital. The infant reportedly consumed formula that has now been linked
The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is
The New York Times reported this afternoon:
A Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.
ByHeart, the company linked to a botulism outbreak in infants, shut down one of its manufacturing plants
Since this outbreak broke early last Saturday, I have learned far too much about Infant Botulism. I have now spoken with a half dozen experts and nearly a dozen parents of victims whose illnesses span from February 2025 to a few days ago. Interestingly, several of the early 2025 cases identified ByHeart formula as a
November 13, 2025
One additional Washington resident has been added to this outbreak, bringing the total to 10 cases – 9 Washington residents and 1 Oregon resident. All cases report illness onsets before the cheese was recalled on October 24, 2025.
November 6, 2025
Samples of Twin Sisters Creamery cheese have tested positive for two
The lawsuits filed Wednesday could be the first of many legal actions against ByHeart, said Bill Marler, a Seattle food safety lawyer who represents Dexter.
“This company potentially faces an existential crisis,” he said.
The parents of at least two babies sickened in an infantile botulism outbreak are suing the makers of the ByHeart baby
One thing about preparing for a lawsuit is digging deep into the facts and the science. One of the recent refrains in this ByHeart infant formula Botulism Outbreak, is how could we have know? Well, you likely could have. Here are some abstracts of discussion of that risk.
Infant botulism is now the most common
ByHeart Brand Linked to Outbreak that Sickened 15 in 12 states
Bainbridge Island, WA – A lawsuit was filed today in court on behalf of Stephen and Yurany Dexter, parents of E.D.( a minor), against ByHeart, Inc. The Dexter’s are represented by Marler Clark, The Food Safety Law Firm and O’Steen, MacLeod & Combs PLC
