Baby formula maker ByHeart is recalling all of its products amid an outbreak of infant botulism likely tied to its powdered formula.
Since August, 15 cases have been reported across 12 states, nearly all among babies between 16 days and around 5 months old, according to the Food and Drug Administration.
After the FDA announced Saturday that it was investigating the outbreak and its link to ByHeart’s organic Whole Nutrition Infant Formula, the company recalled two lots of the product. ByHeart then expanded the recall Tuesday to include all batches of the formula, both in cans and “anywhere packs” — small, sealed pouches.
“The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority,” ByHeart’s co-founder and president, Mia Funt, said in a statement. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.”
Infant botulism arises when babies ingest food contaminated with Clostridium botulinum bacteria, which produce a toxin that affects the body’s nervous system. The infection can cause constipation, poor feeding, 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 with “suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula.” All of those infants were hospitalized.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the FDA said in an update Tuesday. “Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.”
The cases linked to 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 instructed parents and caregivers to immediately stop using any ByHeart infant formula products and keep a close eye on children who consumed it recently, as botulism can take weeks to develop.
If a child does not develop symptoms within 30 days, the agency says to throw the formula away. If a child does develop symptoms, however, the FDA advises that parents or caregivers hold on to the product for testing. Children who consumed ByHeart formula and are exhibiting possible botulism symptoms should receive immediate medical attention.
The New York City-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 bring clarity to families who are understandably concerned, as currently, no U.S. or imported formula is required to be tested for Clostridium botulinum.”
The California Public Health Department was first to report the observed increase in infant botulism cases among babies who consumed ByHeart formula.
“As the FDA and CDPH continue their investigations, we stand ready to partner with them at every step, providing full access to our facilities and unopened cans, without restriction,” ByHeart said in an open letter issued Tuesday.
Most recalls of infant formula in the past few years have occurred because of potential contamination with a different type of bacteria, Cronobacter sakazakii, which can also be life-threatening in infants. In 2022, Abbott Nutrition, one of the country’s top formula producers, recalled several brands of powdered infant formula after complaints of bacterial infections in infants who consumed the 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 not able to definitively link the illnesses to contamination at an Abbott facility. Abbott said at the time that there was “no evidence” to demonstrate a link.