ByHeart

ByHeart is an infant formula company that markets a whole nutrition infant formula sold directly through its own online store, including promotional discounts on larger orders. The company positions its work around infant nutrition science, ingredient selection and product safety.

Since a November 2025 recall, ByHeart's public communications have centered on a Clostridium botulinum outbreak investigation conducted in cooperation with the U.S. Food and Drug Administration. The company published an Action Plan covering C. botulinum-specific testing protocols, enhanced supplier and ingredient quality assurance, manufacturing and facility improvements, and the creation of an independent Food Safety Advisory Council. Genetic sequencing data was submitted to a public federal database, and whole genome sequencing linked samples from a supplier lot of Organic Whole Milk Powder, a ByHeart formula sample, and a clinical sample from a child with infant botulism. The FDA concluded onsite inspections of ByHeart facilities without identifying deficiencies that could explain the root cause, while continuing to investigate a powdered milk ingredient produced by a third-party supplier. As of June 2026, the company stated the FDA had no further questions on its investigation findings, corrective actions, testing protocols and proposed preventative controls, with remaining steps outstanding before production resumes.

Business model

ByHeart sells infant formula to consumers, with its website operating an e-commerce storefront offering promotional discounts on qualifying order values.

Latest developments

On June 3, 2026 the FDA concluded facility inspections without identifying deficiencies explaining the outbreak's root cause. On June 10, 2026 ByHeart released its Action Plan, and on June 23, 2026 it introduced its Advanced C. botulinum Safety Protocol alongside research published in Frontiers in Microbiology. On June 26, 2026 the company said the FDA had reviewed its findings, corrective actions and testing protocols and confirmed it had no further questions, with additional steps remaining before production resumes.