ByHeart
| Company type | Private |
|---|---|
| Industry | Infant formula manufacturing |
| Founded | 2016 |
| Founder | Mia Funt, Ron Belldegrun |
| Headquarters | New York City , United States |
| Products | Infant formula |
ByHeart is a U.S.-based infant formula manufacturer established in 2016 by siblings Mia Funt and Ron Belldegrun, with its headquarters located in New York City. The company introduced its inaugural formula in March 2022 amid a nationwide shortage of infant formula, becoming the first new FDA-registered domestic infant formula producer in more than 15 years. Since its market debut, ByHeart's products have been associated with two bacterial contamination events: Cronobacter sakazakii in 2022 and a nationwide Clostridium botulinum outbreak in 2025, which resulted in botulism cases affecting 31 infants.
History
ByHeart was created with the objective of formulating infant nutrition closely aligned with breast milk, utilizing the latest advances in nutritional science. In 2019, the company acquired a manufacturing facility in Reading, Pennsylvania, positioning itself among the limited number of U.S. formula producers capable of comprehensive end-to-end production.
In June 2021, ByHeart became the first American infant formula brand to receive the Clean Label Project Purity Award, which tests for over 500 contaminants including heavy metals and pesticides.
After launching its product during the national shortage in March 2022, ByHeart expanded its operations through acquisitions: Cascadia Nutrition, an FDA-registered blending and packaging plant in Oregon (January 2023), and another facility located in Allerton, Iowa.
By August 2023, ByHeart's infant formula reached major retail outlets with distribution in over 1,000 Target stores. Early in 2024, it broadened its presence to more than 1,100 Walmart locations and secured entry into Whole Foods Market as well as Wegmans. By May 2024, its products were available across Publix stores nationwide.
In December 2024, Denice Torres—formerly president of McNeil Consumer Healthcare at Johnson & Johnson—joined ByHeart’s board of directors. The company launched the "Anywhere Pack," a convenient portable feeding option for infants, in May 2025.
Botulism contamination
In November 2025, ByHeart voluntarily recalled two batches of infant formula after reports emerged of 13 infants hospitalized with botulism traced to their product. Initially, ByHeart stated that FDA testing found no toxins nor a link to their formula; however, the California Department of Public Health confirmed contamination with Clostridium botulinum type A spores in their products. While the founders acknowledged the positive test result, they contended that testing an already opened container "does not provide scientific evidence to establish causation." The California Department of Public Health issued guidance advising parents to discontinue use of ByHeart formula. After two more cases surfaced, the recall was extended nationwide. Independent third-party analyses commissioned by ByHeart also identified Clostridium botulinum spores within unopened containers.
By November 14, 2025, there were reports of 23 infants across 13 states with suspected or confirmed botulism linked to ByHeart Whole Nutrition formula; this figure increased to 31 cases spanning 15 states by November 19. Multiple parents initiated legal action against ByHeart due to the contamination and related health impacts.
Ingredients
ByHeart's Whole Nutrition Infant Formula incorporates a proprietary protein blend engineered to replicate components of human breast milk. Its formulation includes lactoferrin, alpha-lactalbumin, an 80:20 ratio of whey to casein proteins resembling that found in colostrum, lactose as the exclusive carbohydrate source, partially hydrolyzed proteins, organic prebiotics, along with DHA and ARA fatty acids. The product is free from corn syrup, gluten, genetically modified organisms (GMOs), maltodextrin, soy, DHA derived via hexane extraction, synthetic growth hormones, and palm oil.
Clinical trials
In 2022, ByHeart conducted a randomized controlled trial funded internally, involving more than 300 infants. The findings, published in the Journal of Pediatric Gastroenterology and Nutrition, demonstrated that their formula was not inferior to a commercial comparator in promoting infant growth and indicated enhanced gastrointestinal tolerance.
Regulatory oversight
In December 2022, ByHeart initiated a voluntary recall of five infant formula batches due to possible contamination with Cronobacter; no cases of illness were reported.
Between December 2022 and February 2023, the FDA carried out inspections at ByHeart's Reading, Pennsylvania facility as well as those operated by Mead Johnson Nutrition (Reckitt) and Perrigo Wisconsin, LLC. Warning letters were issued citing regulatory non-compliance. ByHeart responded by submitting several corrective action plans.
The FDA later confirmed that ByHeart had resolved the identified issues and stated it "does not recommend that parents or caregivers discard or refrain from purchasing any specific infant formula." Currently, there are no outstanding FDA inquiries concerning these matters for the company. Following this, ByHeart expanded its production capabilities and quality compliance by acquiring two additional manufacturing sites.