The recent infant botulism outbreak linked to ByHeart formula has led to a nationwide recall, raising significant concerns within the food safety community. Health authorities discovered a connection between the outbreak and ByHeart’s products, a situation that is considered unusual given the generally low risk of infant botulism associated with formula. So far, 23 infants have been hospitalized after consuming ByHeart formula, though no fatalities have been reported.
Critics have pointed out that ByHeart’s initial response to the crisis downplayed the severity of the situation. Mia Funt, the company’s co-founder, stated in a video that there was “no reason to believe that infant formula can cause infant botulism,” which some experts interpreted as a dismissal of the evidence. Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, criticized ByHeart for what she termed as aggressive denial of evidence presented against them.
Former FDA food safety director Susan Mayne noted that while ByHeart’s later communications regarding the outbreak expressed a greater urgency, the initial statements failed to communicate the seriousness of the matter properly. She attributed this to the company’s relative inexperience in handling such crises.
The company, founded in 2016, has carved a niche in the infant formula market aiming at health-conscious consumers, with emphasis on organic ingredients and a patented protein blend similar to breast milk. ByHeart’s products are widely available across major retailers in the U.S. at a premium price point of $42 per can.
The backlash against ByHeart intensified on social media, with consumers expressing outrage over how the recall was managed. Families affected by the outbreak have started filing lawsuits against the company. The FDA issued a warning letter to ByHeart in August 2023, citing deficiencies in its Pennsylvania facility, where subsequent inspections revealed serious issues.
Amidst the controversy, experts are urging the need for increased scrutiny on all infant formula manufacturers to ensure consumer safety, especially as the number of infant botulism cases in the U.S. has risen alarmingly in recent months. The Centers for Disease Control and Prevention typically report about 100 cases a year, but with 84 cases reported from August to early November 2025, there are growing concerns regarding the neglect of safety protocols regarding infants’ diets, notably the risk posed by contaminated honey, which is not safe for infants under 12 months.
These recent incidents highlight the crucial need for improving safety practices in the infant formula industry, particularly following the Abbott Nutrition recall that revealed vulnerabilities in the supply chain. As the FDA continues to address safety standards, experts are hopeful that lessons learned from the ByHeart crisis will lead to more robust protections for vulnerable populations.