Organic baby formula manufacturer ByHeart recalls all of its products amid infant botulism outbreak
Parents have been warned to "immediately discontinue use” of a brand of baby formula as manufacturer recalls all products amid an outbreak of infant botulism.
Organic baby formula manufacturer ByHeart has recalled ALL of its products - amid an outbreak of infant botulism. The brand has called on parents to dispose of all products sold across the US.
It comes after at least 15 babies, in 12 US states, were reported to have been taken ill since August, with more cases pending, according to health chiefs. All of the affected babies were taken to hospital after consuming ByHeart formula, officials said, though no deaths have been reported.
Today (November 11), company bosses expanded a voluntary recall of two products announced on Saturday to all ByHeart goods, including ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula.
Infant botulism is rare - but serious - and affects babies under a year old, as their gut microbiomes have not matured. Symptoms include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing and breathing problems, among others, and anyone showing signs of the illness is urged to get medical attention.
ByHeart sells around 200,000 cans of formula a month online and in stores, including big-name chains Target, Walmart, Albertsons and Whole Foods. Dr Devon Kuehn, chief medical officer, said anyone with ByHeart products at home should "immediately discontinue use and dispose of the product".
The US Food and Drug Administration (FDA) is investigating 84 cases of infant botulism detected since August, with 36 consuming infant formula - more than third ByHeart products.
"This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States," an FDA spokesperson said.
Now, ByHeart bosses have said the company is working with the FDA on the recall "despite the fact that no unopened ByHeart product has tested positive" for contamination. "This action underscores ByHeart’s core mission: protecting babies above all else," a company spokesperson added.
Health chiefs in California previously confirmed a sample from an open can of ByHeart baby formula fed to an infant who got sick contained bacteria that causes the toxin linked to the botulism outbreak.