A total of 37 infants have been hospitalized due to an outbreak of infant botulism linked to ByHeart powdered infant formula, federal health authorities report, Baltimore Chronicle.
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) stated that cases of “suspected or confirmed” infant botulism have now been reported in 17 states, including Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin. The total case count increased by six from the previous update on November 20, 2025, rising from 31 to 37 infants hospitalized.
According to the FDA, onset dates for the 36 cases with available data range from August 9, 2025, to November 19, 2025. Of the 35 infants for whom age and sex data were available, ages ranged from 16 to 264 days, with 15 female. No deaths have been reported to date.
All affected infants had consumed various lots of ByHeart Whole Nutrition powdered infant formula. Laboratory testing is ongoing to confirm certain cases, according to FDA updates. The multistate investigation is being conducted jointly by the FDA, CDC, and the California Department of Public Health Infant Botulism Treatment and Prevention Program, along with other state and local health authorities. Authorities are working to identify the exact source of contamination.
ByHeart initially issued a voluntary recall of two batches of its Whole Nutrition Infant Formula on November 8, 2025, following FDA notification of a wider investigation into the outbreak. On November 11, the company expanded the recall to include all cans and single-serve Anywhere Pack sticks of its formula nationwide.
Testing conducted by ByHeart revealed that some samples contained Clostridium botulinum bacteria, which produces the toxin causing botulism. Of 36 samples tested from three lots, five returned positive results for Clostridium botulinum Type A. The company cautioned that all product lots could be potentially contaminated and advised parents and caregivers to immediately stop using the formula.
Infant botulism is a rare but serious condition caused by Clostridium botulinum spores, which can grow in a baby’s intestines and release a toxin affecting the nervous system. Symptoms may include poor feeding, constipation, drooping eyelids, decreased facial expressions, low muscle tone, difficulty swallowing, or weak cry. The CDC recommends urgent medical attention if any of these symptoms appear in infants who consumed the recalled formula.
ByHeart is offering full refunds for products purchased on or after August 1, 2025, via its website. Parents can contact the company at 866-201-9069 for further instructions on returns and refunds.
Earlier we wrote that First Human Case of H5N5 Bird Flu Strain Fatal in Washington State.
