Federal health officials have confirmed a disturbing outbreak of infant botulism linked to contaminated baby formula that has sickened more than three dozen infants across the United States. The Food and Drug Administration reports 37 confirmed or suspected cases connected to ByHeart brand infant formula.
The Outbreak Details and Recall
The FDA announced the outbreak on November 8, with cases reported between August 9 and November 19 of this year. All affected infants required hospitalization after consuming ByHeart powdered formula, with ages ranging from approximately 2 weeks to 9 months old.
ByHeart, a New York-based manufacturer of organic infant formula, recalled all its products sold in the U.S. on November 11. The company represents about 1% of the U.S. infant formula market and had been selling approximately 200,000 cans monthly before the recall.
California health officials confirmed that testing of an open can of ByHeart formula fed to a sick infant contained the type of bacteria that causes botulism. The company's own laboratory tests also confirmed contamination in some samples.
Geographic Spread and Legal Consequences
The outbreak has affected families across multiple states, including Arizona, California, Idaho, Illinois, Kentucky, Maine, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin.
Multiple families have filed lawsuits against ByHeart in federal courts, alleging the formula was defective and the company was negligent in selling contaminated products. The lawsuits seek financial compensation for medical expenses, emotional distress, and other damages suffered by affected families.
Understanding Infant Botulism
Infant botulism typically affects fewer than 200 babies annually in the United States. According to recent Centers for Disease Control and Prevention records, 133 cases had been reported as of September 20, compared to 145 cases throughout all of last year.
The infection occurs when a specific type of bacteria produces toxins in the large intestine. Infants are particularly vulnerable because their underdeveloped gut microbiomes cannot prevent bacterial spores from germinating and producing dangerous toxins.
Medical experts note that symptoms can take up to 30 days to appear after exposure. Warning signs include poor feeding, loss of head control, drooping eyelids, flat facial expression, and a "floppy" appearance. Babies may also experience difficulty swallowing or breathing.
Treatment and Historical Context
The only available treatment for infant botulism is BabyBIG, an intravenous medication derived from the blood plasma of adults immunized against botulism. Developed by California's infant botulism program, this treatment shortens hospital stays and reduces illness severity.
This outbreak marks the first confirmed case of infant botulism tied to powdered formula, according to research studies. While previous sporadic cases have been linked to baby formula, no outbreaks had been confirmed until now.
The situation differs significantly from the 2021-2022 formula shortage crisis triggered by Abbott Nutrition recalls. That incident involved a different bacteria and led to nationwide shortages, while ByHeart's market share is small enough that supply disruptions are unlikely.
FDA inspectors have visited ByHeart's production facilities in Allerton, Iowa, and Portland, Oregon as the investigation continues. The agency has confirmed that ByHeart brand formula is disproportionately represented among sick infants in this ongoing outbreak.
