The recall followed a notification from the U.S. Food and Drug Administration (FDA) regarding a broader investigation into an outbreak of botulism in newborns. The FDA informed the company on November 7th of 83 cases of botulism in infants since August 2025, including 13 infants who consumed ByHeart milk and were hospitalized in 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
The recall includes two batches of ByHeart Whole Nutrition infant formula with batch codes 251261P2 and 251131P2, with an expiry date of December 1, 2026 and global product number 5004496800.
The Food and Drug Administration (FDA) confirmed that no direct link between infant formula and the illness has been established. However, tests conducted by the California Department of Public Health on a can of ByHeart powdered milk given to an infant with botulism revealed the presence of bacteria that produce botulinum toxin.
Infant botulism is a rare but potentially fatal condition that usually affects infants under 12 months of age. It occurs when spores of the bacterium Clostridium botulinum enter the infant's intestines and grow to produce botulinum toxin.
Symptoms include constipation, muscle weakness, drooping eyelids, weak crying, and, in severe cases, difficulty breathing. The contaminating food does not contain the toxin directly, but rather spores that produce the toxin within the body. Honey is the most common food associated with the disease, so it is advised not to give it to infants under one year old.
Treatment includes intravenous botulinum toxin (BIG-IV), along with supportive care such as hospitalization, respiratory support, and intravenous or tube fluid or nutrition as needed. Although death is rare, full recovery may take months or years.
ByHeart confirmed that the recall is a precautionary measure, as the FDA has not established any direct link between infant formula and cases of poisoning, and there is no historical precedent for this.
Mia Fant, co-founder and CEO of the company, stated: "The safety of every infant who uses our milk is our top priority. While there is no confirmation of contamination, the voluntary recall reflects our commitment to transparency and the safety of babies and their parents."
Consumers can check the batch code and expiry date on the bottom of the box.