Laboratory tests suggest that all ByHeart infant formula products could be contaminated with bacteria that cause botulism, following an outbreak that has affected dozens of babies.
Testing of 36 formula samples from three different product lots found five samples positive for Clostridium botulinum type A, the company said Monday on its website. “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the statement read.
At least 31 infants in 15 states who consumed ByHeart formula have fallen ill since the outbreak began in August, according to federal and state health authorities. Additional cases linked to formula consumption have been reported as far back as November 2024, though they are not officially included in the outbreak count.
Medical experts noted that the bacteria can be unevenly distributed in powdered formula, meaning not all infants who consume it will necessarily become ill, but all children under 1 year old are at risk.
ByHeart issued a nationwide recall of all formula on Nov. 11, but some products reportedly remain on store shelves, according to the FDA and state officials. Parents and caregivers are urged to stop using the formula immediately and watch for symptoms, which can appear up to 30 days after consumption.
Parents raise concerns over early ByHeart formula botulism cases
Infant botulism occurs when spores germinate in the gut and release a toxin. Symptoms include constipation, difficulty feeding, drooping eyelids, a flat facial expression, and muscle weakness. The condition is a medical emergency requiring prompt treatment.
Since Aug. 1, at least 107 infants nationwide have received BabyBIG, an IV medication for botulism. Normally, fewer than 200 infants are treated annually for the disease.
Consumers who purchased ByHeart formula on or after Aug. 1 through the company’s website are eligible for a full refund under an expanded policy. Reports of illness can be submitted via FDA consumer complaint coordinators or the online MedWatch form.
Source: AP