ByHeart Recalls Infant Formula Amid Botulism Outbreak Investigation

ByHeart has voluntarily recalled all batches of its Whole Nutrition Infant Formula amid an ongoing investigation by the U.S. Food and Drug Administration (FDA) into a multistate outbreak of infant botulism.

As of November 14, 2025, 23 cases of suspected or confirmed infant botulism have been reported across 13 states, with all affected infants having consumed ByHeart formula. The FDA has not identified a direct link between the formula and the illnesses but noted that ByHeart products are disproportionately represented among the cases, considering the brand accounts for approximately 1% of U.S. infant formula sales.

ByHeart's Co-Founder and President, Mia Funt, stated, "The safety and well-being of every infant who uses our formula is our absolute highest priority."

Parents and caregivers are advised to discontinue use of ByHeart formula immediately and monitor infants for symptoms such as constipation, poor feeding, loss of head control, and difficulty swallowing. If any of these symptoms develop, seek medical attention promptly.

The FDA continues to investigate the outbreak and has not identified other infant formula brands or shared exposures posing a risk at this time.