ByHeart is expanding a recall of its organic baby formula to include all of its products amid a recent outbreak of infant botulism, the company announced. Previously, only two batches were recalled.
The recall follows notification from the FDA of an ongoing investigation into approximately 83 cases of infant botulism reported nationwide since August. Thirteen of those infants had consumed ByHeart formula at some point, the company said.
No deaths have been reported.
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California health officials said they had "tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases."
Infant botulism is a rare but potentially serious illness. Symptoms can include constipation, feeding difficulties, weak muscle tone, drooping eyelids, trouble breathing and, in severe cases, respiratory failure.
ByHeart products were sold by national retailers including Amazon, Kroger, Walmart, Whole Foods and Target.
According to The Associated Press, the company produces formula powder at a plant in Allerton, Iowa, and then ships it to a site in Portland, Oregon, for canning and distribution. FDA inspectors were at the Portland plant on Monday, officials told the outlet.
