ByHeart recalls infant formula after botulism outbreak affects babies

Baby food company ByHeart is recalling all batches of its complete nutrition infant formula after an outbreak of infant botulism in several states.

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

Federal officials still have not identified a direct link between any infant formula and these cases, and there is no historical precedent for infant formula causing botulism in infants, according to ByHeart. However, the company has begun recalling all batches of ByHeart Infant Formula in all sizes and shapes “out of an abundance of caution.”

ByHeart also recommends that parents and caregivers immediately stop using and dispose of any ByHeart formula.

No deaths have been reported, but during the ongoing outbreak investigation, the California Department of Public Health’s Infant Botulism Prevention and Treatment Program discovered an increase in the number of Type A botulism cases among infants consuming ByHeart 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 using our formula is our absolute top priority,” Mia Font, co-founder of ByHeart, said in a statement, adding that the company takes “any potential safety concerns seriously, and acts quickly to protect families.”

ByHeart has voluntarily recalled two batches of its complete infant formula after the FDA began investigating 83 cases of infant botulism in the United States since August 2025. (US Food and Drug Administration)

“Although there has been no testing by ByHeart or regulatory agencies confirming the presence of Clostridium botulinum spores or toxins 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,” Font added.

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Although botulism occurs naturally in the environment such as soil, vegetables and dust, it is extremely uncommon in dairy products or infant formula, according to the recall notice published by the FDA.

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

However, although infant botulism is rare, it can be life-threatening to babies. It poses a serious and potentially fatal risk to infants when Clostridium botulinum spores (a type of bacteria) are ingested and begin to grow inside the baby’s intestines. The bacteria produce a toxin that affects the baby’s nerves and muscles.

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Infected babies may experience symptoms including constipation, poor feeding, drooping eyelids, slow pupils, decreased muscle tone, difficulty sucking and swallowing, weak or variable crying, general weakness, difficulty breathing and possibly even apnea, according to the recall.