All ByHeart infant formula products may be at risk of contamination with botulism-causing bacteria, prompting a nationwide recall as dozens of babies fall ill.
The organic formula maker said Monday that laboratory testing found Clostridium botulinum type A in five of 36 samples taken from three separate lots. Because powdered formula can contain bacteria unevenly, the company said it “cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.”
Federal and state health officials report that 31 babies in 15 states have been sickened since August after consuming ByHeart formula. Additional infants treated for botulism as far back as November 2024 also consumed ByHeart products, though those cases are not included in the official outbreak count.
ByHeart recalled all of its formula nationwide on November 11. However, some product has remained on store shelves despite the recall, according to the U.S. Food and Drug Administration and state officials.
Parents and caregivers are urged to stop using the formula immediately and monitor infants for symptoms, which may take up to 30 days to appear. Warning signs include constipation, difficulty feeding, drooping eyelids, facial weakness, reduced muscle tone, and lethargy.
At least 107 infants nationwide have been treated with BabyBIG — an IV medication specifically used for botulism — since August 1, officials said. A typical year sees fewer than 200 cases in total.
Infant botulism occurs when babies ingest spores that germinate in the intestines and produce a toxin. Infants under 12 months old are at highest risk.
ByHeart expanded its refund policy Monday to cover all purchases made through its website on or after August 1. Consumers may report illnesses to the FDA through MedWatch online forms or via local consumer complaint coordinators.
The recall marks a significant setback for ByHeart, which markets itself as a premium organic formula brand. Parents are now turning to alternative feeding options amid ongoing formula supply challenges nationwide.