Formula with “cleanest ingredients” recalled after 15 babies get botulism

A manufacturer known for its specialty baby formula, which claimed to feature the "cleanest ingredients" and had received a "Purity Award," is recalling all of its products following a troubling outbreak of infant botulism affecting multiple states. Health officials from California and federal agencies first reported the outbreak over the weekend, initially identifying 13 cases across 10 states. As of Tuesday, that number has risen to 15 cases in 12 states, with all affected infants requiring hospitalization, although fortunately, no fatalities have been reported. The California Department of Public Health (CDPH) was the first to alert the public about the outbreak, which is linked to the ByHeart Whole Nutrition Infant Formula. This particular formula is notable as the sole source of the BabyBIG treatment, a therapeutic option consisting of human-derived antibodies that combat the effects of botulism. Health officials detected an unusual increase in infant botulism cases and subsequently traced them back to the ByHeart formula. Testing of leftover product samples confirmed the presence of Clostridium botulinum, the bacteria responsible for the illness. Erica Pan, the director of CDPH, emphasized the seriousness of the situation, stating, "Infant botulism is a very rare disease that occurs when infants ingest spores from the bacteria, leading to potentially severe symptoms like muscle weakness and breathing difficulties if not treated promptly. We strongly advise parents to cease using ByHeart formula immediately." Initially, ByHeart voluntarily recalled two specific lots of its Whole Nutrition Infant Formula on November 8. However, following the identification of additional cases and further discussions with the Food and Drug Administration, the company decided to expand the recall to include all of its products nationwide. In a statement on their website, co-founders Mia Funt and Ron Belldegrun announced the comprehensive recall, stating, "We have decided to voluntarily recall all ByHeart formula nationwide—this includes both our cans and our single-serve Anywhere Pack™ sticks."