Baby nutrition company ByHeart is recalling all batches of its Whole Nutrition Infant Formula following a multi-state outbreak of infant botulism.

Thirteen of the 83 cases of infant botulism reported across the United States since August 2025 involved infants who had consumed ByHeart-brand powdered infant formula, according to the Food and Drug Administration (FDA). All 13 affected infants were hospitalized, with cases reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

Federal officials still haven’t identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism, according to ByHeart. However, the company initiated the recall for all batches of its ByHeart Infant Formula across all sizes and formats “out of an abundance of caution.” 

ByHeart also recommends parents and caregivers immediately discontinue use and dispose of any ByHeart formula.

ByHeart decided to remove any potential risk from the market by issuing a recall of its Whole Nutrition Infant Formula following notification from the FDA of a broader ongoing investigation into a recent outbreak of infant botulism. (U.S. Food and Drug Administration)

There haven’t been any reported deaths, but during the ongoing investigation into the outbreak, the California Department of Public Health and Infant Botulism Treatment and Prevention Program discovered an increase in the number of botulism type A infections among infants consuming ByHeart powdered infant formula between August and November 2025. 

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Federal officials are still testing the formula and are expected to have results “in the coming weeks.”   

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“The safety and well-being of every infant who uses our formula is our absolute highest priority,” ByHeart co-founder Mia Funt said in a statement, adding that the company takes “any potential safety concern extremely seriously, and act quickly to protect families.” 

ByHeart has voluntarily recalled two batches of its Whole Nutrition Infant Formula after the FDA began investigating 83 U.S. cases of infant botulism since August 2025.  (U.S. Food and Drug Administration)

“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,” Funt added.

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Although botulism is naturally occurring in the environment like soil, select vegetables and dust, it is extremely uncommon in dairy products or infant formula, according to the recall notice posted by the FDA. 

The FDA has not identified a direct link between any infant formula cases of infant botulism, ByHeart wrote in its recall announcement. (U.S. Food and Drug Administration)

However, even though infant botulism is rare, it can be life-threatening for babies. It poses a serious and fatal risk to infants when Clostridium botulinum spores (a type of bacteria) are swallowed and start growing inside the baby’s intestines. The bacteria makes a toxin that affects the baby’s nerves and muscles.

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Infants that become infected may have symptoms including constipation, poor feeding, ptosis, (a drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty and possibly respiratory arrest, according to the recall.