IEH Laboratories & Consulting Group tested un-opened cans of ByHeart product. IEH tested thirty-six samples from three lots. IEH found positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots. Based on these results, ByHeart cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.
The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate the multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula is contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country. As of November 19, 2025, this outbreak includes 31 infants with suspected or confirmed infant botulism from 15 states: Arizona 3, California 4, Idaho 1, Illinois 2, Kentucky 1, Maine 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 3, Pennsylvania 1, Rhode Island 1, Texas 6 and Washington 2.
The California Department of Public Health (CDPH) is now investigating six additional cases of infant botulism in babies who consumed ByHeart formula between November 2024 and June 2025, months before the current outbreak began. These cases, which predate the wave of illnesses that started in August 2025, have not yet been definitively linked to the formula, but they have added urgency to the ongoing scrutiny of ByHeart’s safety standards and manufacturing practices.
Infant botulism, the illness associated with the bacteria, is a rare but serious condition. It occurs when ingested spores germinate in an infant’s intestines and release a neurotoxin. Early symptoms often include constipation, followed by lethargy, weakened crying, and a loss of head control. While the condition typically requires hospitalization and can be severe, the fatality rate is below one per cent with appropriate medical care.
Recalled product was sold through online marketplaces and was shipped to customers outside of the United States. Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall. More information on international distribution, including a list of countries where consumers received recalled product The ByHeart infant formula recall impacts markets outside the United States. Customer information provided by Amazon shows that a limited quantity of recalled ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and Virgin Islands.
FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations. FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.