Investigation Launched into ByHeart Baby Formula Linked to Botulism Outbreak

Mon Nov 10 2025 01:33:26 GMT+0200 (Eastern European Standard Time)

Health officials are investigating a botulism outbreak linked to ByHeart baby formula, which has affected infants across 10 states, prompting an urgent recall.

Thirteen infants across ten states have been affected by a botulism outbreak linked to ByHeart Whole Nutrition Infant Formula, prompting health officials to issue a recall of specific lots of the product. The bacteria causing botulism, known for producing toxins in the intestines, has raised concerns among state and federal health officials, leading to further testing of the formula. While the outbreak has resulted in hospitalization but no fatalities, the FDA is scrutinizing 83 cases of botulism linked to this incident. Authorities are also evaluating the broader implications for the US infant formula supply chain, given the historical context of formula safety.

Preliminary tests indicate that ByHeart baby formula may contain the type of bacteria responsible for a botulism outbreak, say California health officials.

At least 13 infants from 10 states have been hospitalized due to this outbreak, which has raised immediate health concerns, although no deaths have been reported.

The California Department of Public Health has strongly advised consumers to stop using the ByHeart Whole Nutrition Infant Formula, particularly the recalled lots, while further tests are conducted on the product. ByHeart, based in New York, recalled the lots this weekend.

Details of the Botulism Outbreak

The CDC reports that the infants who fell ill were between 2 weeks and 5 months of age, with cases scattered across various states including Arizona, California, and New Jersey. The incidents are linked directly to the powdered formula, which has a best-by date extending to December 2026.

California health officials tested samples from a can of the formula fed to a sick baby and found a bacterium that produces the botulin toxin but stated that more testing is necessary to confirm its presence. ByHeart confirmed that they are collaborating with the relevant health authorities on this investigation.

Understanding Infant Botulism

Infant botulism is generally rare, affecting fewer than 200 babies annually in the U.S. It is caused by a type of bacterium that generates toxins in the intestinal tract. Infants, particularly those under one year of age, may contract the illness after exposure to spores from environmental sources or through contaminated honey.

Symptoms of botulism in babies can include poor feeding, weakness, and difficulty in breathing, which may require ventilation support in severe cases. Treatment is available through a specific medication called BabyBIG, which has been administered to those affected in this outbreak.

Impact on Formula Supply

Despite the outbreak, health officials reassure that there will be no nationwide infant formula shortage resulting from this incident, as ByHeart accounts for a small fraction of national sales. In contrast, a previous crisis involving Abbott formula led to widespread shortages and severe complications due to different contamination issues.

The FDA continues to monitor the broader implications of this outbreak and has announced plans to overhaul the U.S. food supply, with a specific review of infant formula ingredients under 'Operation Stork Speed'.