US infant-formula producer ByHeart has recalled all its products following an outbreak of botulism under investigation by federal health authorities.
According to the US Centers for Disease Control and Prevention (CDC), 15 infants with botulism were fed ByHeart Whole Nutrition powdered infant formula before getting sick.
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The broader inquiry by the CDC and the US Food and Drug Administration (FDA) has been examining a rise in 84 infant botulism cases since August.
In a statement posted online, ByHeart co-founders Mia Funt and Ron Belldegrun said: “We have decided to voluntarily recall all ByHeart formula nationwide. It’s important that you know that neither we, nor the FDA or CDC, have found clostridium botulinum spores or toxins in any unopened can of ByHeart formula.”
The action applies to ByHeart Whole Nutrition Infant Formula cans and the Anywhere Pack.
On 8 November, the group initiated a voluntary recall of two batches of infant formula, which has now been expanded. As of 11 November, no deaths have been reported.
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By GlobalDataInfant botulism is a rare but serious condition caused when clostridium botulinum spores are ingested and colonise the intestines, leading to the production of botulinum neurotoxins in infants’ immature gut.
Reported symptoms include constipation, poor feeding, difficulty swallowing and breathing difficulties.
“At this moment, the most important thing for you to know is that all ByHeart product must be discarded,” Funt and Belldegrun said in their statement.
Parents who have used ByHeart Whole Nutrition Infant Formula are being urged to remain alert as symptoms can take several weeks to appear.
ByHeart said it is testing “every batch of formula with an independent third‑party laboratory”.
“We are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities,” Funt and Belldegrun added.
Founded in 2016, ByHeart broke into the US infant-formula market at the height of the supply crisis that rocked the sector in 2022.
