A new University of Minnesota public-health alert is putting parents on edge, warning that powdered infant formula has been tied to a multistate spike in infant botulism cases. Investigators have identified 51 suspected or confirmed cases across 19 states from March 2022 through December 2025. Every affected infant was hospitalized, and so far no deaths have been reported. The unusual pattern first popped onto officials’ radar when California’s infant botulism treatment program saw a sharp uptick in requests for BabyBIG® therapy.
What the UMN alert found
CIDRAP’s Public Health Alerts report details an investigation led by the California Department of Public Health that linked many of the sick infants to ByHeart Whole Nutrition powdered infant formula. According to the report, whole-genome sequencing matched bacterial isolates from infant stool to organisms found in both finished product and ingredient samples, which strengthened the epidemiologic evidence. The authors note that infant botulism is still rare, yet this cluster represents the first known multistate outbreak in the United States tied to a powdered formula product.
Laboratory findings and recalls
The FDA reports that testing detected Clostridium botulinum type A in multiple samples. That included an unopened finished-product sample that matched a clinical isolate, as well as organic whole-milk powder used by the manufacturer. Those positive results, along with ongoing analyses, led the agency to recommend a voluntary recall. In response, ByHeart expanded its November 2025 recall to cover all powdered products. The FDA and state partners say they are still checking store shelves for recalled formula and coordinating with retailers to pull any remaining inventory.
What parents and clinicians should do
Federal guidance urges parents and caregivers to stop using any ByHeart Whole Nutrition formula immediately. They are asked to watch infants for signs such as feeding trouble, loss of head control, difficulty swallowing, or decreased facial expression, and to seek medical care right away if symptoms develop, according to the CDC. Caregivers should photograph or write down lot numbers and best-by dates and keep opened containers labeled "DO NOT USE" in case testing is needed later. Clinicians are advised to consult the California Infant Botulism Treatment and Prevention Program and to begin treatment with BabyBIG® promptly for suspected cases rather than waiting for laboratory confirmation.
Local response and legal fallout
Local health departments moved quickly, issuing alerts and working with stores to pull the recalled product, as San Diego County sounds alarm reported. Families of affected infants have filed federal lawsuits alleging the formula was defective and that ByHeart was negligent, according to reporting by the AP. Public-health leaders say the episode has renewed calls for stricter testing of powdered milk ingredients and clearer oversight of specialty formula manufacturers.
Why this matters
CIDRAP’s analysis underscores that rapid surveillance, strong laboratory capacity, and tight interagency coordination were key to spotting this uncommon risk. With testing and investigations still underway, officials say the top priorities now are making sure recalled products are fully off shelves and ensuring clinicians can access BabyBIG® for any suspected infant botulism cases.
