ByHeart, a producer of organic baby formula, has recalled all of its products sold across the United States. This decision comes in response to an outbreak of infant botulism that has affected at least 15 infants in 12 states since August. All affected babies were hospitalized after consuming ByHeart formula, although no fatalities have been reported. The recall was expanded from two specific lots announced just days earlier to include all products currently in consumers' homes and on store shelves. This includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The company typically sells around 200,000 cans of infant formula each month through various retailers, including Target, Walmart, Albertsons, and Whole Foods. Dr. Devon Kuehn, ByHeart's chief medical officer, advised parents and caregivers to “immediately discontinue use and dispose of the product.” The recall was initiated in close collaboration with the U.S. Food and Drug Administration (FDA), even though no unopened ByHeart products have tested positive for contamination. California health officials confirmed that a sample from an open can of ByHeart formula, which was given to a sick infant, contained the bacteria responsible for the toxin linked to the outbreak. ByHeart stated, “This action underscores ByHeart’s core mission: protecting babies above all else.” The FDA is currently investigating 84 cases of infant botulism reported since August. Among these, 36 cases involved infants who consumed formula, with more than a third of those cases linked to ByHeart products. The FDA noted that ByHeart formula is disproportionately represented among the sick infants, despite the brand accounting for only about 1% of all infant formula sales in the U.S. ByHeart manufactures its formula powder in Allerton, Iowa, and ships it to a facility in Portland, Oregon, for canning and distribution. FDA inspectors were present at the Portland plant on Monday. In addition to the recall, ByHeart is testing every batch of formula through an independent third-party laboratory. The company is also providing health officials with full access to its facilities and sharing test results with regulators as they become available. Infant botulism is a rare but serious illness that affects babies under one year old, whose gut microbiomes are still developing. The illness occurs when infants ingest bacteria that produce spores, leading to toxin production in the gut. Symptoms can include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, and breathing problems. Infants exhibiting these symptoms require immediate medical attention. The primary treatment for the infection is BabyBIG, an intravenous medication derived from the blood plasma of individuals immunized against botulism.