Tests conducted on ByHeart infant formula tied to a botulism outbreak show that all of the company’s products may have been contaminated, according to the company.
Laboratory testing of 36 formula samples from three different product lots found that five samples contained Clostridium botulinum type A, the bacteria that can cause infant botulism. ByHeart stated that based on the results, it cannot rule out the risk that all formula across all product lots may have been contaminated.
At least 31 babies in 15 states who consumed ByHeart formula have been sickened in an outbreak that began in August, according to federal and state health officials. Additional infants who drank ByHeart formula were treated for botulism as far back as November 2024, though those cases are not included in the current outbreak totals.
Health officials said the bacteria can be unevenly distributed in powdered formula, meaning not all infants who ingest it will become ill. All infants under the age of 1 are considered at risk.
ByHeart issued a nationwide recall of all its infant formula on Nov. 11. Despite the recall, some product has remained on store shelves, according to state officials and the U.S. Food and Drug Administration.
Parents and caregivers are advised to stop feeding ByHeart formula to infants immediately and monitor for symptoms, which may take up to 30 days to appear. Infant botulism occurs when ingested spores produce a toxin in the child’s intestine. Symptoms include constipation, difficulty feeding, drooping eyelids, flat facial expression, and weakness in the arms, legs, or head. The condition is considered a medical emergency and requires immediate treatment.
Since Aug. 1, at least 107 babies nationwide have been treated for botulism with the IV medication BabyBIG, according to health officials. In a typical year, fewer than 200 infants receive treatment for the illness.
Illnesses linked to the outbreak can be reported through an FDA consumer complaint coordinator or the FDA’s online MedWatch system.
ByHeart stated that consumers who purchased formula through the company’s website on or after Aug. 1 are eligible for a full refund, expanding its previous refund policy.
