Company Overview
About ByHeart
If your baby became ill after using ByHeart Whole Nutrition Infant Formula, our team can help you understand whether your family may have a claim. CDC and FDA linked the formula to infant botulism, and every lot was recalled. A parent doesn’t need to resolve the ingredient investigation before asking for legal help.
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. CDC’s final count included 48 infants across 17 states (28 confirmed and 20 probable cases), all hospitalized, 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.
Our ByHeart formula outbreak page covers the affected products, medical findings, and lawsuit developments.
The Ingredient Investigation and Nara Organics
Testing connected contaminated ByHeart formula and a milk-powder ingredient to a sick infant. FDA identified Dairy Farmers of America as the processor for ByHeart’s supplier, Organic West Milk. In August 2026, agencies said the evidence points to a common contamination source with the separate Nara Organics formula outbreak. FDA still hasn’t determined whether the milk was contaminated before or during drying. The two brands’ case counts remain separate.
Failed Recall Response
FDA found recalled formula still on shelves at more than 175 retail locations in 36 states and sent warning letters to Target, Walmart, Kroger, and Albertsons in December 2025. Where and when a family purchased formula may therefore matter to its claim. Our botulism lawyers can review the records and explain the available options.