ByHeart infant formula maker recalls all products amid botulism outbreak

Infant formula maker ByHeart is recalling all of its products due to an outbreak of infant botulism likely linked to its powdered formula.

Since August, 15 cases have been reported in 12 states, almost all in babies aged 16 days to about 5 months, according to the Food and Drug Administration.

After the FDA announced Saturday that it was investigating the outbreak and its connection to ByHeart’s Whole Nutrition organic infant formula, the company recalled two lots of the product. ByHeart then expanded the recall Tuesday to include all lots of the formula, both in cans and in “anywhere packages” — small sealed pouches.

“The safety and well-being of every infant who uses our formula is and always will be our top priority,” Mia Funt, co-founder and president of ByHeart, said in a statement. “This nationwide recall reflects our commitment to protecting babies and providing families with clear, actionable information. Along with this recall, we are conducting a thorough investigation to do our part and get the answers parents expect and deserve.”

Infant botulism occurs when babies ingest food contaminated with the bacteria Clostridium botulinum, which produces a toxin that affects the body’s nervous system. The infection can cause constipation, poor eating, loss of head control and difficulty swallowing. Untreated, it can ultimately lead to paralysis and death, according to the Centers for Disease Control and Prevention. No deaths have been reported in the current outbreak.

The FDA said Tuesday that 84 infants nationwide have received treatment for infant botulism since Aug. 1. Of that total, the agency is investigating 15 cases of “suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula.” All of these infants were hospitalized.

“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially since ByHeart represents approximately 1% of all infant formula sales in the United States,” the FDA said in an update Tuesday. “Investigations continue but have not identified any other brands of infant formula or shared exposures that pose a risk to infants.”

Cases linked to the ByHeart formula have been reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, according to the FDA.

The agency asked parents and caregivers to immediately stop using ByHeart infant formula and closely monitor children who have consumed it recently, as botulism can take weeks to develop.

If a child does not develop symptoms within 30 days, the agency asks them to throw away the formula. However, if a child develops symptoms, the FDA advises parents or guardians to keep the product for testing. Children who have consumed ByHeart formula and experience possible symptoms of botulism should receive immediate medical attention.

The New York-based company said it has invited the FDA and other public health agencies to test unopened cans of its formula to “provide reliable evidence that will help provide clarity for families who are understandably concerned, as currently, no U.S. or imported formula is required to be tested for Clostridium botulinum.”

The California Department of Public Health was the first to report the observed increase in cases of infant botulism in babies who consumed ByHeart formula.

“As the FDA and CDPH continue their investigations, we stand ready to collaborate with them every step of the way, providing full access to our facilities and unopened cans, without restriction,” ByHeart said in an open letter published Tuesday.

Most infant formula recalls in recent years have occurred due to potential contamination with another type of bacteria, Cronobacter sakazakii, which can also be life-threatening for infants. In 2022, Abbott Nutrition, one of the nation’s leading infant formula producers, recalled several brands of powdered infant formula after complaints about bacterial infections in infants who consumed these products. The recall contributed to a national formula shortage in 2022.

The CDC later determined that Cronobacter infections may have contributed to the deaths of two infants in Ohio, but was unable to definitively link those illnesses to contamination at an Abbott facility. Abbott said at the time that there was “no evidence” showing a link.