In brief
ByHeart infant formula is under scrutiny following a botulism outbreak affecting at least 31 babies across 15 states since August. Recent tests revealed contamination in various product lots, leading to a nationwide recall. Health officials are advising caregivers to halt usage immediately and monitor infants for symptoms as the company expands its refund policy for affected customers.
Tests of ByHeart infant formula tied to a botulism outbreak that has sickened dozens of babies showed that all of the company’s products may have been contaminated.
Laboratory tests of 36 samples of formula from three different lots indicated that five samples contained the bacteria responsible for the rare and potentially deadly illness.
“Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” stated the company.
As of now, at least 31 babies in 15 states who consumed ByHeart formula have been affected. Other infants were treated for botulism as far back as November 2024, although those cases are not officially counted in this outbreak.
Clostridium botulinum type A, the detected bacteria, can be unevenly distributed throughout powdered formula. Medical experts emphasize that while not all infants who ingest it will become ill, all babies under one year of age are at risk.
Parents and caregivers are advised to stop feeding this formula to infants immediately and watch for symptoms, which may take up to 30 days to appear. Symptoms of infant botulism include constipation, difficulty sucking or feeding, drooping eyelids, and overall weakness.
ByHeart recalled its formula nationwide on November 11, but some products have reportedly remained on store shelves despite the recall. The company is now offering a full refund for purchases made on their website since August 1.
At least 107 babies have been treated with an IV medication known as BabyBIG since the outbreak began, which is significantly higher than the usual annual count.
To report illnesses linked to this outbreak, individuals can contact an FDA consumer complaint coordinator or submit an online MedWatch form.
