ByHeart Infant Formula Recall: Health Risks from Botulism Outbreak

Wed Nov 26 2025 04:43:38 GMT+0200 (Eastern European Standard Time)

Tests reveal potential contamination of all ByHeart infant formula products linked to a botulism outbreak that has sickened at least 31 babies across the U.S.

Recent laboratory tests show that all ByHeart infant formula products may be contaminated with Clostridium botulinum type A bacteria, which can cause serious illness in infants. At least 31 cases of botulism among babies have been reported since the outbreak began in August, prompting a nationwide recall of the formula. Parents are urged to monitor their children for symptoms.

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 revealed that five samples contained Clostridium botulinum type A bacteria, known for causing the rare but potentially deadly illness. The company stated, “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.”

A total of at least 31 infants from 15 states have been reported sick after consuming ByHeart formula since the outbreak started in August, according to federal and state officials. Furthermore, there have been cases of other infants being treated for botulism linked to ByHeart formula dating back as far as November 2024.

Clostridium botulinum can be unevenly distributed in powdered formula. While not all babies will fall ill after ingestion, all infants under age 1 are considered at risk, according to medical experts.

ByHeart recalled all of its formula nationwide on November 11. However, some of the product remains on store shelves despite the recall. Parents and caregivers are urged to stop feeding the formula to babies immediately and monitor them for symptoms, which may take up to 30 days to appear.

Symptoms of infant botulism include constipation, difficulty feeding, drooping eyelids, flat facial expression, and weakness in limbs. The illness is a medical emergency, requiring immediate treatment.

Health officials have treated at least 107 infants across the nation for botulism with an IV medication called BabyBIG since August 1. Typically, fewer than 200 infants are treated for the illness in a year.

Those who purchased ByHeart through the company’s website on or after August 1 are eligible for a full refund, according to updated policy.