ByHeart Whole Nutrition Infant Formula products have been recalled urgently following the hospitalization of 31 infants across 15 states after consuming allegedly ‘contaminated’ formula milk.
The infants were affected by infant botulism, a serious illness that can result in paralysis or even be fatal.
Initially, on November 8, ByHeart recalled two batches of its Whole Nutrition Formula after reports of infant botulism potentially linked to the product surfaced.
The Food and Drug Administration (FDA) reported that about 83 cases of infant botulism have been identified nationwide since August, with 13 cases involving infants who had consumed ByHeart formula.
“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.”
On November 19, the company discovered Clostridium botulinum – the bacterium behind botulism – in several formula samples.
All products have been recalled as a precaution while authorities seek to determine the underlying cause.
ByHeart stated: “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 has reached 15 states, including Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, as per the FDA’s report.
The products were also available online, meaning other regions could potentially be impacted.
The CDC notes that early signs of infant botulism include constipation, followed by difficulties with feeding, loss of head control, trouble swallowing, and reduced facial expressions.
“If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization,” states the CDC.
As the recall was announced, the FDA urged parents to remain alert if their child consumed the formula, and to seek medical attention promptly if their baby shows any signs of illness.
The CDC advises thoroughly cleaning any surfaces or bottles that may have come into contact with the formula, using hot soapy water.