11/11/2025
ByHeart has sent an important update regarding a recall on select formula batches. As parents, and as a team deeply committed to safety and transparency, our priority is to support the healthcare community and the families we serve. As valued members of our community and as champions of child and infant health, we want to reach out to you directly to keep you informed about the recent, ongoing investigation on infant botulism in the United States. In response, ByHeart has initiated a voluntary recall of two batches of ByHeart Whole Nutrition Infant Formula.
ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA noted that 13 infants received ByHeart formula.
On November 9, 2025, we were made aware by the California Department of Public Health (CDPH) that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. While there is no historical precedent of infant formula or dairy ingredients used in infant formula causing infant botulism, nor have the FDA nor CDPH found Clostridium botulinum in an unopened can of ByHeart infant formula to-date, we take the results from the previously-opened sample seriously.
We are actively working in partnership with CDPH, FDA, and CDC on their comprehensive investigation, and we are currently pending results from an expedited, third-party, independent test on unopened cans. Without test results from an unopened can, there is currently no confirmed link between ByHeart’s infant formula and infant botulism. We acknowledge that Clostridium botulinum is a bacteria that exists naturally in the environment—in places like soil, dust, and even vegetables—meaning that an opened can may be contaminated in multiple ways.
