Phoebe Tonks
All ByHeart Whole Nutrition Infant Formula products have been urgently recalled after 31 babies were hospitalized after ingesting 'contaminated' formula milk.
The infants, who are spread across 15 different states, have all been struck down by infant botulism, a dangerous illness which can lead to paralysis and even death.
Initially, just two batches of ByHeart’s Whole Nutrition Formula were recalled on November 8, after several cases of infant botulism were reported, believed to be linked to the product.
According to the Food and Drug Administration (FDA), roughly 83 cases of infant botulism have been found nationwide since August, with 13 of these linked to infants who had ingested ByHeart formula at some point in their lives.
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“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,” the FDA said 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 revealed that testing had revealed Clostridium botulinum - the bacteria that causes botulism - had been detected in several samples of formula.
As a precaution, all products have been recalled while authorities work to identify the root cause of the problem.
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 currently spans 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.
In addition, the products were also sold online, meaning other states may also potentially be affected.
According to the CDC, initial symptoms of infant botulism, are constipation, followed by trouble with feeding, loss of head control, difficulty swallowing, and decreased 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 says.
Announcing the recall, the FDA advised parents to stay vigilant if their child has taken the formula, and to seek medical advice immediately if their baby becomes unwell.
The CDC also advises thoroughly washing anything the formula may have come into contact with, such as kitchen surfaces or bottles, with hot soapy water.