ByHeart Baby Formula Recall: What You Need to Know
ByHeart, a manufacturer of organic baby formula, has issued a nationwide recall of all its products due to an expanding outbreak of infant botulism. The recall comes after at least 15 babies in 12 states have been sickened since August, with more cases pending, according to state and federal health officials. All of the infants were hospitalized after consuming ByHeart formula, and fortunately, no deaths have been reported.
The company initially recalled two lots of its formula on Saturday but has since expanded the recall to include all products in consumers’ homes and in stores. This includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The decision to broaden the recall was made after the FDA informed the company of two additional cases of infant botulism in babies who had consumed ByHeart formula.
What Led to the Recall?
According to ByHeart’s cofounders, Mia Funt and Ron Belldegrun, the company’s decision to recall all products was made in collaboration with the FDA, despite no unopened ByHeart product testing positive for contamination. The FDA is still investigating the cause of the outbreak, and ByHeart has agreed to test every batch of formula with an independent third-party laboratory and allow access to its facilities and unopened products for testing.
California health officials have confirmed that a sample from an open can of ByHeart baby formula fed to an infant who got sick contained the type of bacteria that causes the toxin linked to the outbreak. The FDA is investigating 84 cases of infant botulism detected since August, with 36 of those cases involving infant formula, and more than a third of those cases involving ByHeart formula.
What is Infant Botulism?
Infant botulism is a rare and serious illness that occurs in babies under the age of 1, whose gut microbiomes are immature. It is caused when infants consume bacteria that contain spores that produce a toxin in the gut. Symptoms of infant botulism include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing, and breathing problems, among others. Babies who develop these symptoms need immediate medical attention, and the sole treatment for the infection is BabyBIG, an IV medication made from blood plasma of people immunized against botulism.
ByHeart produces formula powder at a plant in Allerton, Iowa, and then ships it to a site in Portland, Oregon, for canning and distribution. The company sells about 200,000 cans of infant formula a month online and in stores such as Target, Walmart, Albertsons, and Whole Foods. Parents and caregivers who have the formula in their homes are advised to immediately discontinue use and dispose of the product.
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