BYHEART RECALLS TWO BATCHES OF INFANT FORMULA AMID FDA INFANT BOTULISM PROBE
ByHeart, a next-generation baby nutrition company based in New York, has voluntarily recalled two specific batches of its Whole Nutrition Infant Formula (batch codes 251261P2 and 251131P2, both with a “Use by” date of 01 Dec 2026) out of an abundance of caution.
The action follows an FDA notification on November 7, 2025, about an ongoing nationwide investigation into approximately 83 reported cases of infant botulism since August 2025, of which 13 infants had consumed ByHeart formula at some point. The FDA has emphasized that no direct link has been established between any infant formula and the outbreak, and there is no historical precedent of infant formula causing infant botulism, a rare but serious illness caused by Clostridium botulinum spores that can lead to symptoms including constipation, poor feeding, drooping eyelids, weak cry, muscle weakness, and potentially life-threatening respiratory issues.
No ByHeart products have tested positive for contaminants, and the company stresses that botulism spores are naturally occurring in environmental sources, such as soil and dust, and are not typically associated with dairy-based formulas. Co-founder and President Mia Funt stated that the recall reflects the brand’s unwavering commitment to infant safety and transparency, even in the absence of confirmed risk. Only these two batches are affected; all other ByHeart products remain available.
Parents who have the recalled batches should immediately stop using them, dispose of the cans, and contact ByHeart at [email protected] or 1-833-429-4327 (24/7) for free replacement. Any infant showing botulism symptoms should receive urgent medical attention, and adverse events can be reported directly to the FDA.
