The Outbreak: 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 a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be 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. CDC and state health authorities are investigating confirm infant botulism cases from late 2024 and early 2025 to determine if they are linked to the consumption of ByHeart formula.
Recall: 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.
International Online Sales: Additionally, 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.
Product Tested Positive for Botulism: As part of the investigation, ByHeart tested unopened infant formula products retained at its facility. According to ByHeart, third party laboratory analysis of some of these samples identified Clostridium botulinum, which produces the toxin that is making infants sick in this outbreak. ByHeart states that it will continue to investigate these findings and perform ongoing testing to identify the source of contamination.
Symptoms: 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.