Preliminary testing by California health authorities detected bacteria capable of producing botulism toxin in ByHeart Whole Nutrition Infant Formula, triggering a voluntary recall of two product lots. The affected codes are 206VABP/251261P2 and 206VABP/251131P2, each labeled “Use by 01 Dec 2026.” The U.S. Food and Drug Administration (FDA) has advised parents and caregivers to stop using cans from these lots, record the lot and date information printed on the bottom of the container, and dispose of the product. Officials emphasized that additional laboratory work is underway to confirm the early findings and to determine whether contamination is isolated to the recalled lots.
Scope of Illness and Clinical Response
Health agencies are investigating at least 13 infant botulism cases across 10 U.S. states, and all of the affected infants had consumed ByHeart formula at some point prior to illness, according to public updates. The states disclosed by authorities include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. While no deaths have been reported, the infants required hospital care, reflecting the condition’s potential severity in babies. Clinicians have administered BabyBIG, an intravenous antitoxin used for infant botulism, as part of standard treatment in cases identified in the current investigation. Parents are urged to watch for symptoms that can develop gradually over days or weeks, including constipation, poor feeding, weak cry, drooling, decreased muscle tone, difficulty swallowing, and breathing problems.
Investigation Status and Company Position
The FDA and the Centers for Disease Control and Prevention (CDC) are conducting a multistate investigation to identify the contamination source and assess any potential spread beyond the recalled lots. Federal updates indicate that since August 2025, regulators have received reports of about 83 infant botulism cases nationwide, of which 13 infants were reported to have received ByHeart formula at some point. The CDC says epidemiologic data suggest ByHeart’s Whole Nutrition Infant Formula “might be contaminated with Clostridium botulinum and has made infants sick,” while cautioning that investigations are still in progress and additional confirmation testing is pending.
ByHeart stated that “more testing is needed” to determine whether the specific toxin-producing bacteria are present, noting that the organism belongs to a broader bacterial family that includes harmless strains. The company said it initiated the recall “out of an abundance of caution” in response to the FDA’s broader inquiry and is cooperating with federal and state agencies. ByHeart also reiterated that powdered infant formula comprises a small share of the company’s sales relative to the overall market and that the action is not expected to disrupt national supply.
Safety Guidance for Parents and Supply Context
Officials advise families who purchased the recalled lots to cease use immediately, note the lot numbers and use-by dates, and discard the product. Households should sanitize surfaces that came into contact with the powder and wash hands thoroughly after handling it. Parents should contact a pediatrician or seek urgent care if a baby develops signs consistent with botulism, especially poor feeding, floppiness, weak cry, or breathing difficulty. Health departments and the CDC continue to stress that infant botulism is rare in the United States, typically affecting fewer than 200 infants per year, and that honey should never be given to infants under 12 months because of a known botulism risk.
Regulators emphasized that the recall is targeted to two lots and that there is no evidence of a broader disruption to the nation’s infant formula supplies at this time. Retailers and healthcare providers have been asked to check inventory, notify families, and follow standard return or disposal procedures for the recalled cans. The FDA noted it will release additional updates as laboratory work proceeds and as investigators review manufacturing and ingredient records under a stepped-up oversight effort.
