ByHeart infant botulism outbreak ends with 48 babies sickened

Health officials have declared the end of a rare infant botulism outbreak that sickened 48 babies who consumed ByHeart formula, with no new cases reported since mid-December, the Centers for Disease Control and Prevention announced Thursday.

The outbreak, which began in 2023, prompted widespread concern among parents and healthcare providers across the United States. All affected infants required hospitalization, though fortunately no deaths were reported. Three cases initially included in the count were later determined to be unrelated to botulism.

Investigators have yet to pinpoint exactly how the organic, whole-milk powdered baby formula became contaminated with the bacteria that can cause potentially fatal illness in infants under one year old. The botulism outbreak in commercial infant formula is unprecedented in both size and scope, according to food safety experts.

California’s Infant Botulism Treatment and Prevention program first detected an alarming increase in infant botulism cases among babies who had consumed ByHeart formula in August. This discovery triggered a cascade of public health responses.

New York-based ByHeart initially recalled two specific lots of formula in early November but quickly expanded the recall to include all its products just days later. Federal health officials subsequently indicated they couldn’t rule out contamination in products manufactured since the company launched in March 2022. Retailers nationwide removed the premium formula from shelves.

The U.S. Food and Drug Administration’s investigation has identified 17 different strains of the illness-causing bacteria in samples collected from patients, finished formula cans, and ingredients. While these findings provide important evidence, they haven’t led to definitive conclusions about the root cause of the contamination. Earlier statements from FDA officials suggested the powdered whole milk used in manufacturing might be a potential source.

ByHeart, which marketed its product as having “next-to-breast milk benefits,” held approximately 1% of the U.S. infant formula market before the recall. The company sold roughly 200,000 cans monthly at about $42 per can. Parents who chose this premium-priced formula often cited its advertised health advantages as a primary reason for their selection.

Infant botulism occurs when babies ingest botulism spores that then germinate in the intestine, producing a potent neurotoxin that attacks the nervous system. The disease can cause severe symptoms including muscle weakness, breathing difficulties, and paralysis. While death rates for infant botulism were historically as high as 90%, they have dropped to less than 1% with modern treatment protocols.

The only effective treatment for infant botulism is an intravenous medication known as BabyBIG (Botulism Immune Globulin Intravenous). This specialized treatment is derived from the pooled blood plasma of adults immunized against botulism. California’s Infant Botulism Treatment and Prevention program remains the sole worldwide source of this life-saving treatment.

The ByHeart outbreak highlights the ongoing challenges in ensuring food safety in infant nutrition products. Powdered infant formula is not sterile, and manufacturers must maintain rigorous testing and quality control measures to prevent contamination. Industry experts note that while formula recalls are not uncommon, outbreaks of this nature and scale are exceedingly rare.

For affected families, the outbreak has caused significant distress beyond the immediate health concerns. Many parents reported difficulties finding suitable alternative formulas during a period when the U.S. formula market was still recovering from previous shortages.

As the investigation continues, health officials emphasize that parents should always consult healthcare providers about any concerns regarding infant formula safety and remain vigilant for recall notices from manufacturers and regulatory agencies.