ByHeart has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula out of "an abundance of caution".
This follows a notification from the US Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism.
Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants.
It occurs when Clostridium botulinum spores are ingested and colonise the intestinal tract, producing botulinum neurotoxins in the immature gut of infants.
Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, low muscle tone, weak or altered cry, respiratory difficulty and possibly respiratory arrest.
The FDA has an ongoing investigation of infant botulism among babies in the US.
ByHeart was notified by the FDA on November 7, 2025, of an estimated 83 cases of infant botulism that were reported nationwide since August 2025.
Of these, the FDA also noted that 13 infants received ByHeart formula at some point.
The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.
However, ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.
The company says it adheres to the highest standards of Global and US recommendations for product testing and safety and that no ByHeart product has tested positive for any contaminants.
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, co-founder and President.
“We take any potential safety concern extremely seriously and act quickly to protect families. As parents ourselves, we understand the concern this news may raise."
"This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents."
"While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”