The number of sick children in an outbreak of childhood botulism poisoning has jumped to 23. The outbreak has been linked to ByHeart organic baby formula powder.
ByHeart Inc. has recalled all of its infant formulas, including cans and disposable sticks. Consumers are urged to check their homes for the presence of the mixture and stop using it immediately.
The number of patients is now 23, up from 13 on November 11. The sick babies were scattered across 13 states and were hospitalized. No deaths were reported.
Earlier this month, ByHeart was notified that at least 84 cases of botulism poisoning in infants had been reported since August. 1. Surveys are conducted to determine if infants have been fed ByHeart formula. The Food and Drug Administration's first report, when 13 infants became ill, said all patients received ByHeart formula.
As part of the investigation into the outbreak, authorities in several states collected leftover ByHeart baby food for testing. On November 8, preliminary laboratory results reported by the California Department of Public Health indicated the presence of botulinum toxin-producing bacteria in an open can of ByHeart infant formula (Lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional testing is currently underway, with results expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not exclude the presence of bacteria in the product.
The FDA's investigation, including on-site inspections and sample collection, continues to determine the location of the contamination.
In 2023, the FDA sent out a warning letter describing numerous food safety problems at one of its manufacturing plants. The agency said responses to the concerns contained in the letter were inadequate. However, the plant was allowed to continue operating without interruption.
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