Preliminary tests by California health officials have found that ByHeart baby formula contained bacteria capable of producing the toxin responsible for a recent botulism outbreak. The outbreak has affected at least 13 infants across 10 states, though no deaths have been reported.
The California Department of Public Health advised, “Consumers in possession of this product should stop using it immediately.” Further testing on ByHeart Whole Nutrition Infant Formula is ongoing as state and federal agencies continue their investigation into the outbreak, which began in mid-August. In response, ByHeart recalled two lots of its powdered formula over the weekend.
According to the U.S. Centers for Disease Control and Prevention (CDC), all affected infants—ranging from 2 weeks to 5 months old—were hospitalized after consuming ByHeart powdered formula. Cases have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
The U.S. Food and Drug Administration (FDA) confirmed that ByHeart officials agreed to recall two lots of Whole Nutrition Infant Formula with a best-by date of December 2026. Testing by California health authorities on a can fed to an ill infant indicated “the presence” of bacteria linked to botulism toxin seen in other cases; confirmation may take several days.
ByHeart stated that “more testing is needed” to determine if the specific bacteria causing botulism are present in their product. The company explained that the detected bacteria belong to a large family commonly found in nature but not all strains cause illness. “We take this very seriously,” the company said Sunday.
The FDA is currently investigating reports of 83 infant botulism cases since August, including those connected to ByHeart’s formula.
Infant botulism is rare in the United States with fewer than 200 cases annually. It results from toxins produced by certain bacteria in infants’ intestines after exposure to spores found naturally in dust or soil or through contaminated food such as honey. Symptoms can include poor feeding, muscle weakness (“floppiness”), loss of head control and difficulty swallowing or breathing.
Dr. Steven Abrams from the University of Texas noted there have been no previously confirmed outbreaks tied directly to powdered infant formula: “This would be extremely rare,” he said.
Treatment for infant botulism involves BabyBIG—a medication developed by California’s Infant Botulism Treatment and Prevention Program using blood plasma from immunized adults—which shortens hospital stays and reduces severity. All children involved in this outbreak received BabyBIG according to CDC statements.
Officials say there is no risk of widespread infant formula shortages due to this incident; ByHeart accounts for about 1% of national sales and distributes its products online and through retailers nationwide. This situation differs from the significant shortage experienced during late 2021-2022 when Abbott Nutrition recalled major brands following contamination concerns at its Michigan plant—a crisis triggered after four infants fell ill with cronobacter sakazakii infections (https://www.fda.gov/news-events/press-announcements/fda-investigation-abbott-nutrition-infant-formula-supply).
In 2022, ByHeart also recalled five batches after detecting cronobacter sakazakii at its packaging facility; later in 2023, it received an FDA warning letter highlighting areas needing corrective action (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/byheart-inc-661154-07122023).
Federal officials are now re-examining regulations around infant formula ingredients as part of “Operation Stork Speed”—the first comprehensive review since 1998—under orders from Health Secretary Robert F. Kennedy Jr., who has tasked the FDA with evaluating current standards based on feedback from industry experts and public comments.
