Eight additional infants have been hospitalized in a widening outbreak of infant botulism linked to baby formula, with some affected babies as young as 16 days old.
The Food and Drug Administration (FDA) first announced a recall of ByHeart Whole Nutrition Infant Formula on Nov. 8, citing two batches tied to several cases of infant botulism. On Nov. 20, the agency expanded that recall to include all ByHeart formula products, saying that epidemiologic and laboratory evidence suggests the formula may be contaminated with Clostridium botulinum, the bacteria that causes botulism.
In a Nov. 21 update, the U.S. Centers for Disease Control and Prevention (CDC) reported that a total of 31 babies have been hospitalized. Available FDA data indicates all sickened infants are under 1 year old, including newborns as young as 16 days.
The CDC says early symptoms can begin with constipation, but may progress to difficulty feeding (including sucking and swallowing), a weak or altered cry, and reduced head control. If untreated, infant botulism can lead to progressive muscle weakness and paralysis, potentially causing breathing problems and requiring weeks of hospitalization.
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ByHeart said in a statement on its website that it is investigating the source of the contamination and conducting ongoing testing. The company urged parents and caregivers to stop using ByHeart formula immediately, watch for signs of infant botulism, and seek medical care right away if symptoms develop.
The FDA says cases have been reported across 15 states: Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Texas has reported the highest number of cases so far.
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One Kentucky mother, Hanna Everett, whose four-month-old daughter Piper was hospitalized after consuming the formula, said her family hopes the illness won’t have long-term effects. She added that her daughter will need speech and feeding therapy, but is mostly back to her usual self aside from ongoing bottle-feeding struggles and fatigue.
