Company Overview
About ByHeart
ByHeart, Inc. is a venture-capital-funded infant formula startup founded in 2016 by siblings Mia Funt and Ron Belldegrun. Headquartered in New York City, the company raised approximately $395 million across six funding rounds before its entire product line was recalled in November 2025 due to Clostridium botulinum contamination.
The First Outbreak of Its Kind
In November 2025, ByHeart became the center of the first-ever outbreak of infant botulism linked to powdered infant formula. The CDC and FDA identified 48 infants across 17 states who were hospitalized with suspected or confirmed infant botulism after consuming ByHeart Whole Nutrition Infant Formula. All 48 required treatment with BabyBIG antitoxin. No deaths were reported. The CDC declared the outbreak over on February 26, 2026, though the nationwide recall of ByHeart formula remained in effect.
Whole genome sequencing traced the contamination to organic whole milk powder used as an ingredient, supplied by Organic West Milk Inc. and processed at a Dairy Farmers of America plant in Fallon, Nevada. FDA testing confirmed Clostridium botulinum Type A in multiple finished product samples and in the raw ingredient.
A Pattern of Food Safety Failures
The 2025 botulism outbreak was not ByHeart’s first contamination incident. In December 2022, the company recalled five batches of formula after a sample tested positive for Cronobacter sakazakii. ByHeart’s internal investigation incorrectly attributed the positive result to “a laboratory error,” a conclusion the FDA later cited as inadequate.
In August 2023, the FDA issued a warning letter for ByHeart’s Reading, Pennsylvania manufacturing facility documenting severe violations: over 2,700 dead insects in a food production area, mold growth inside a tank designated for clean water storage, recurring roof leaks, temperature control failures during microbiological kill steps, and inadequate sanitation procedures. The facility ceased production in September 2023.
Failed Recall Response
The FDA found recalled ByHeart formula still on store shelves at more than 175 retail locations across 36 states, in some cases more than three weeks after the recall was issued. On December 12, 2025, the FDA sent warning letters to Target, Walmart, Kroger, and Albertsons for failing to remove recalled products. Target had even offered a $2.00 promotional discount on recalled formula during the recall period.
Your Legal Options
If your infant consumed ByHeart formula and was diagnosed with infant botulism, a claim may seek medical expenses, hospitalization costs, future care, lost income for caregivers, and other damages allowed by law. These cases require an individual review because treatment and recovery can differ substantially from one child to another. Our botulism lawyer guide explains the medical evidence and legal process in more detail.