Number of sick infants in ByHeart botulism outbreak continues to grow
The number of sick babies in an outbreak of infant botulism poisoning has jumped to 23. The outbreak has been traced to ByHeart powdered, organic infant formula.
ByHeart Inc. has recalled all of its infant formula, including cans and single serve sticks. Consumers are being urged to check their homes for the formula and stop using it immediately.
The patient count now stands at 23, up from 13 on Nov. 11. The sick babies are spread across 13 states and have been hospitalized. No deaths have been reported.
Earlier this month ByHeart was notified that at least 84 cases of botulism poisoning in infants had been reported since August. 1. Interviews are underway to determine whether the infants were fed ByHeart formula.The first report from the Food and Drug administration, when 13 infants were sick, said all of the patients had been fed ByHeart formula.
As part of the outbreak investigation, officials in several states have collected leftover ByHeart infant formula for testing. On Nov. 8 preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.
FDA’s investigation, including onsite inspections and sample collection, is ongoing to determine the point of contamination.
In 2023 the FDA sent a warning letter outlining numerous food safety issues at one of its manufacturing plants. The agency said responses to problems in that letter were inadequate. However, the plant was allowed to continue operations uninterrupted.
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Source: https://www.foodsafetynews.com/2025/11/number-of-sick-infants-in-byheart-botulism-outbreak-nearly-doubles/
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