An outbreak of infant botulism has sickened at least 39 babies in 18 states who ate contaminated ByHeart Whole Nutrition Infant Formula.
The number of illnesses may continue to grow, as laboratory confirmation for some cases is ongoing.
ByHeart has recalled all of its infant formula products nationwide, but in an update posted on December 3, the U.S. Food and Drug Administration (FDA) said ByHeart formula is still being found on store shelves at Walmart, Target, Kroger, Acme, and Shaw’s.
The FDA is working with state partners and retailers to ensure that these products are immediately removed. This includes all cans of formula and single-serve “Anywhere Pack” sticks.
This is the first outbreak of botulism that has ever been linked to powdered infant formula.
ByHeart has only been on the market in the U.S. since 2022, and it was the first new formula-maker in the U.S. to receive FDA approval in 15 years. ByHeart issued its first recall less than 6 months after its formula hit the market, due to a dangerous bacteria called Cronobacter that was found in a 3rd-party canning facility.
When the botulism recalls began in November 2025, ByHeart defended the safety of its products and invited health officials to test unopened cans of formula.
The testing process has taken weeks, but there are now multiple cans of unopened ByHeart formula that have tested positive for the bacteria that causes botulism, Clostridium botulinum. Investigators are still working to determine at what point the contamination occurred.
Source: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
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