ByHeart recalls all infant formula amid growing botulism outbreak

Federal health officials have expanded their investigation into a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula, as new cases continue to emerge across the United States.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have identified 15 infants hospitalized with suspected or confirmed cases of infant botulism in 12 states. No deaths have been reported.

All affected infants were fed ByHeart Whole Nutrition infant formula before becoming ill, according to the agencies.

The FDA said laboratory results from the California Department of Public Health suggest the presence of Clostridium botulinum, the bacteria that produces botulinum toxin, in an open can of ByHeart formula fed to one of the infants. Additional testing is underway to confirm the finding.

ByHeart initially recalled select lots of its formula on Saturday, but after further reports of illness involving other batches, the company expanded the recall on Tuesday to include all ByHeart Whole Nutrition infant formula products nationwide, regardless of lot number or packaging size. The formula was sold both online and in major retailers across the country.

Parents and caregivers are urged to stop using any ByHeart Whole Nutrition formula immediately and to seek medical attention if their infant shows symptoms such as constipation, poor feeding, difficulty swallowing, loss of head control, or a weak or altered cry. Health officials noted that symptoms can take several weeks to appear.

The CDC confirmed that all 15 infants required hospitalization. Among those with available data, ages range from 16 to 157 days.

States with cases linked to the outbreak (Credit: FDA)

The agency also reported that since August, 84 infants nationwide have received treatment for infant botulism, with ByHeart formula accounting for a disproportionate share of cases despite representing about 1% of U.S. formula sales.

ByHeart co-founders Mia Funt and Ron Belldegrun issued a public apology following the nationwide recall of all ByHeart Whole Nutrition infant formula, saying the decision was made “to ensure your baby’s safety.”

ByHeart said neither the company, the FDA, nor the CDC have found Clostridium botulinum spores or toxins in any unopened cans of its formula but decided to expand the recall after learning from the FDA that two additional infants with botulism had consumed ByHeart products.

The company added that it has begun its own testing of all formula batches and has granted regulators unrestricted access to its facilities and production records.