ByHeart

We founded ByHeart in 2016 as an infant nutrition company. We develop, blend, and manufacture infant formula with a focus on innovation for babies and parents. Our primary product, Whole Nutrition Infant Formula, launched in March 2022. This made us the first new U.S. infant formula manufacturer in 15 years.

Our formula uses organic, grass-fed whole milk and includes alpha-lac and lactoferrin, two proteins found in breast milk. We received the Clean Label Project’s Purity Award and test for 700 contaminants, which is more than the required 400. Our clinical trial showed that babies who used our formula had less spit-up, softer poops, easier digestion, more efficient weight gain, better nutrient absorption, and slept longer between nighttime feeds compared to babies on a leading infant formula. We have secured over $250M in funding.

In November 2025, we initiated a nationwide recall of all our infant formula products due to Clostridium botulinum contamination. An ongoing investigation by the FDA, in collaboration with us, identified genetic matches between a sample of our infant formula and a new sample of whole milk powder collected by the FDA from one of our suppliers. We are implementing new testing protocols for C. botulinum from farms to factories and on every batch of finished infant formula. We are also evaluating additional preventative controls throughout our supply chain and manufacturing process and establishing a Food Safety Advisory Board. All recalled products are eligible for a full refund.

We had previously addressed all issues from an FDA warning letter issued in August 2023, which referenced a February 2023 inspection of our Reading, PA facility. The batches involved in the November 2025 recall were produced at our Allerton, IA plant and canned at our Portland, OR plant, not our Reading, PA facility.

Our mission is to make the best formula in the world. Our goal is to create a future where all parents feel positive about feeding their baby, regardless of the method. We believe in feeding freedom, where well-fed babies benefit from a balanced blend of nature and science. We are committed to offering the best for infant health, aiming to bring science-driven innovation and high levels of quality and safety to families.

Our team includes over 275 people working across the country. We have a fast-paced work environment, with collaboration across regulatory, legal, product safety, and marketing functions. We offer company equity for every employee, and some roles have options for remote work.

We provide health insurance for the whole family:

• Medical, dental, and vision insurance covered at 100% for employees and 90% for their families.
• Flexible paid time off, plus 12+ company holidays and 2 floating holidays.
• 16 weeks of fully-paid parental leave and new parent support, including a free 1-year supply of formula, cozy feeding suites, and paid pumping time.
• An up to 6% 401(k) match.
• Company equity for every employee.