ByHeart

ByHeart is an infant formula brand that manufactures and markets whole nutrition infant formula products for parents seeking an alternative to traditional formula options. The company produces organic whole milk powder-based infant formula sold through its direct-to-consumer channel at ByHeart.com as well as through national retail partners. Its product lineup includes canned infant formula and Anywhere Pack stick formats, designed for convenience and portability for caregiving on the go.

ByHeart positioned itself in the premium infant nutrition segment, emphasizing transparency, clean ingredient sourcing, and rigorous quality standards as key brand differentiators. The company sources organic whole milk powder and other ingredients from third-party suppliers and operates its own manufacturing facilities.

As of November 2025, ByHeart is operating under significant regulatory scrutiny following a voluntary nationwide recall of all product batches — including all canned and stick-format products — issued on November 11, 2025. The recall was initiated in connection with a multistate infant botulism outbreak linked to Clostridium botulinum contamination identified in finished product samples. The company has paused all production, marketing, advertising, and influencer partnerships while cooperating fully with the FDA and CDC investigations.

In response to the outbreak, ByHeart has committed to implementing new and enhanced safety and testing protocols for both ingredients and finished products, identifying new suppliers for certain ingredients, enhancing supplier qualification standards, and establishing an independent Food Safety Council to validate protocols and anticipate future risks. The FDA's root cause investigation, including whole genome sequencing analysis, identified genetic matches between samples from supplier-sourced Organic Whole Milk Powder, finished ByHeart formula, and clinical samples from affected infants. The CDC and FDA declared the outbreak over as of February 26, 2026, though the root cause investigation remains ongoing.

ByHeart is providing full refunds for products purchased on its website on or after August 1, 2025, and directing retail customers to seek refunds through the respective retailers. The company has stated its intent to continue transparent communication with its customer base as it develops enhanced safety measures and works toward eventual resumption of operations.