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Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
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Do not use recalled ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere pack” sticks.
ByHeart infant formula products makes up approximately 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.
Cases jump to 23 in the botulism outbreak tied to baby formula. Here’s what to know.
Nearly two dozen babies in 13 states have been sickened in a growing outbreak of infantile botulism linked to recalled ByHeart infant formula, federal health officials said Friday.
The U.S. Food and Drug Administration reported 23 cases of confirmed or suspected illness in babies who consumed ByHeart formula since August. Thatâs an increase of 10 babies treated for the rare and potentially deadly disease since the outbreak was announced Nov. 8. The most recent case was reported on Nov. 11.
âParents and caregivers should stop using any ByHeart infant formula products immediately,â the FDA said.
ByHeart, a New York-based manufacturer of organic infant formula, has recalled all its products sold jn the U.S. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.
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ByHeart’s ‘bizarre’ response to infant botulism outbreak worries food safety experts
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Sarah Todd returned to reporting in January 2025 after being assignment editor at STAT since October 2022. You can reach Sarah on Signal at sarahlizchar.47.
There are a few unusual things about the infant botulism outbreak that prompted formula maker ByHeart to recall all of its products across the U.S. this week.
The first is that regulators found a link between formula and infant botulism at all. The risk from formula is generally considered very low for the potentially fatal condition, which is caused by bacterial spores found in dust and soil. (Honey contaminated with the spores is a common infant botulism cause.) So far 23 infants as of Friday have been hospitalized after consuming ByHeart formula at some point. No deaths have been reported.
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