ByHeart Baby Formula Outbreak: FDA and CDC Investigate Contamination Concerns
An outbreak of infant botulism linked to ByHeart baby formula has expanded to include all illnesses reported since the company began production in March 2022. Investigations by the FDA and ByHeart are ongoing to determine the cause of the outbreak, with health officials warning that all ByHeart formula produced could be contaminated. The CDC has expanded its probe to include any infant exposed to ByHeart formula since it came on the market over three years ago, with at least 51 infants in 19 states affected by the outbreak.
The outbreak, which has not resulted in any deaths, has seen cases reported in various states, with California having the highest number of cases. ByHeart, a New York-based organic infant formula manufacturer, recalled all its products sold in the U.S. in November 2025. The company, accounting for about 1% of the U.S. infant formula market, had been selling around 200,000 cans of the product monthly.
Affected parents like Andi Galindo and Amy Mazziotti shared their distressing experiences of their infants falling ill with botulism after consuming ByHeart formula. Galindo expressed concern over the manufacturing issues dating back to the beginning, while Mazziotti felt a sense of relief and hope as the cases are now part of the investigation. ByHeart officials stated they are cooperating with federal officials to understand the full scope of related cases.
The FDA conducted inspections at ByHeart plants in Iowa and Oregon, where the formula is produced and packaged, but no results have been released yet. The company previously reported that tests showed bacteria in samples from different lots, leading to the possibility of contamination across all product lots. Infant botulism is a rare disease affecting fewer than 200 babies in the U.S. each year, caused by ingesting botulism bacteria that produce toxins affecting the nervous system. Symptoms can include constipation, poor feeding, and loss of head control, with the sole treatment being an IV medication called BabyBIG.