All ByHeart products have been urgently recalled after 31 infants were hospitalized due to consuming contaminated formula milk.
The affected babies, residing in 15 different states, have been diagnosed with infant botulism, a serious condition that can lead to paralysis and potentially be fatal.
Originally, two batches of ByHeart’s Whole Nutrition Formula were recalled on November 8 after reports of infant botulism cases believed to be linked to the product surfaced.
According to the FDA, around 83 cases of infant botulism have been identified nationwide since August, with 13 cases associated with infants who had consumed ByHeart formula at some point.
“The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism,” stated the FDA in its news release at the time.
“Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.”
However, on November 19, the company announced that tests showed the presence of Clostridium botulinum — the bacteria responsible for botulism — in several formula samples.
As a safety measure, all products have been recalled while authorities work to determine the root cause of the contamination.
In a statement, ByHeart said: “Our core mission has always been protecting babies. After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test cans of ByHeart formula, and conducted a nationwide recall.
“We have just learned that those tests identified Clostridium botulinum in some samples of ByHeart formula. We immediately notified the FDA of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.”
“We continue to urge parents and caregivers to stop using ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.
“We have been working in cooperation with the FDA, and we are investigating every facet of our process – from ingredient-sourcing to our manufacturing process and facilities, packaging, transportation, everything.
“We do not yet know the root cause, but we are committed to finding the answers. We are doing everything we can to ensure this investigation reveals solutions and aids in understanding cases of infant botulism broadly. That’s what parents, the medical community, and you deserve.”
The outbreak affects 15 states, according to the FDA, including Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Additionally, since the products were sold online, other states may also be at risk.
The CDC notes that initial symptoms of infant botulism include constipation, followed by feeding difficulties, loss of head control, trouble swallowing, and diminished facial expressions.
“If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization,” the CDC states.
In response to the recall, the FDA has advised parents to be vigilant if their child has consumed the formula and to seek medical advice immediately if their baby shows signs of illness.
The CDC also recommends thoroughly washing any surfaces or items that may have come into contact with the formula, such as kitchen surfaces or bottles, using hot soapy water.