FDA links ByHeart formula botulism to milk powder
Outbreak spans 19 states; all infant formula recalled
26 January 2026
1 minute read
By: US authorities have linked an outbreak of infant botulism across several states, caused by ByHeart's formula to whole-milk powder, sourced from a supplier, Reuters reported, citing the Food and Drug Administration (FDA) on Friday.
A sample of ByHeart's Whole Nutrition formula tested positive for Clostridium botulinum, matching a culture taken from an affected infant, the FDA said. The samples also matched isolates of organic whole-milk powder sourced from a ByHeart supplier.
Fifty-one cases have been identified in 19 states, the latest on December 10, according to data from the Centers for Disease Control and Prevention. All of New York-based ByHeart's infant formula products have been recalled.
Infant botulism occurs when babies ingest spores of the bacterium Clostridium botulinum, which can grow in their immature digestive systems and produce the toxin. Symptoms include constipation, poor feeding, loss of head control and difficulty in swallowing. In severe cases, infants can develop breathing problems.
"While these results advance FDA's understanding of the outbreak, FDA's investigation is ongoing to determine the source of contamination," the agency said in a statement.
The FDA and the CDC did not identify the supplier.
"As we have gained unique insights through this investigation, we started to develop a set of actions to evolve our testing protocols and manufacturing process to ensure that an outbreak like this does not happen again," ByHeart said in a statement.
The FDA sent warning letters to retailers Walmart, Target, Kroger and Albertsons in December for continuing to sell baby formula linked to infant botulism after the products were recalled.
