The voluntary recall—undertaken in coordination with federal health authorities—comes amid mounting evidence linking ByHeart formula to a disproportionate number of illness cases. While investigations are ongoing, the scale and speed of the company’s response have drawn national attention, raising broader concerns about safety oversight in infant nutrition products.
Organic Formula Manufacturer Initiates Full-Scale Recall across the US
ByHeart, a company producing organic infant formula, has issued a nationwide recall of all its formula products after 15 infants in the United States were hospitalized with suspected or confirmed cases of infant botulism. The decision follows discussions with the Food and Drug Administration (FDA) and growing concerns over potential contamination with Clostridium botulinum, the bacteria responsible for the rare but life-threatening illness.
According to the Centers for Disease Control and Prevention (CDC), the cases span 12 states, with symptoms reported between early August and November. The recall includes all unexpired lots of ByHeart Whole Nutrition Infant Formula as well as single-serve Anywhere Pack sticks. All products were available both online and in national retail chains such as Target, Walmart, Albertsons and Whole Foods.
ByHeart product overrepresentation triggers expanded recall
The recall was initially limited to two production lots, but ByHeart co-founders Mia Funt and Ron Belldegrun confirmed in a public letter that the company decided to recall all formula products after learning of two additional cases possibly linked to their brand. In their statement, they said the move was made “after a call with the FDA… informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point.”
The FDA has reported that out of 84 nationwide cases of infant botulism since August 2025, 36 involved formula consumption, with over 40% of those linked to ByHeart. “This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the agency stated.
Testing by the California Department of Public Health (CDPH) detected Clostridium botulinum in an open can of formula from one of the initially recalled lots. Though no unopened cans have tested positive so far, officials caution that detection of the bacteria is difficult and not always conclusive. The source of contamination remains unknown, and FDA inspectors have visited both ByHeart’s production site in Allerton, Iowa and its canning facility in Portland, Oregon as part of the ongoing investigation.
Health officials urge vigilance as investigation continues
While there have been no deaths reported, all affected infants required hospitalisation. The youngest was 16 days old, with the oldest reported at just over five months. Symptoms of infant botulism include constipation, poor feeding, muscle weakness, drooping eyelids, and in severe cases, respiratory failure. The only treatment available is BabyBIG, an antitoxin administered intravenously, derived from human plasma.
In its recall notice, ByHeart advised parents and caregivers to stop using its products immediately. The company is currently cooperating fully with the FDA and has committed to third-party batch testing, alongside providing unrestricted access to its facilities. The FDA, CDC, and state health departments are continuing their investigation to determine the origin and extent of the contamination. As of 11 November, no other formula brands have been implicated.
Consumers are encouraged to contact their local health providers if their child shows symptoms consistent with infant botulism. Health authorities are also collecting remaining formula samples from affected households for further testing. Although the incident has raised alarms, officials stress that it is not expected to cause a national shortage, as ByHeart products make up less than 1% of the US infant formula market.
