Key facts
- U.S. health officials indicated that powdered whole milk used in ByHeart infant formula may be the source of a botulism outbreak.
- FDA testing found matching bacteria in an unopened can of ByHeart formula and in samples of the organic whole milk powder used to make it.
- The contamination was also detected in a sample of whole milk powder supplied to ByHeart, matching the germ in a finished formula sample.
- ByHeart has recalled all of its products due to the outbreak, which has sickened 51 babies in 19 states since December 2023.
- No new cases have been reported since mid-December, and the FDA stated there is no indication of a broader problem in the infant formula supply.
Powdered whole milk used in ByHeart infant formula may be the source of a botulism outbreak that has sickened 51 babies across 19 states since December 2023, U.S. health officials indicated Friday. Testing by the U.S. Food and Drug Administration (FDA) found the type of bacteria that can cause the illness in samples linked to the formula. The agency discovered that bacteria in an unopened can of formula matched a sample from a sick baby, and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula. FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart, which matched the germ in a finished sample of the company’s formula.
ByHeart officials stated that the new findings suggest they are significantly closer to determining the root cause of the contamination. Neither the FDA nor ByHeart named the supplier of the powdered whole milk. The FDA noted that the findings are not conclusive and the investigation continues to determine the source. There is no indication of a broader problem in the infant formula supply, the agency added.
The New York-based company has been at the center of the outbreak, which was identified in November after a surge in cases in babies who consumed ByHeart formula. No new cases have been identified since mid-December, according to the U.S. Centers for Disease Control and Prevention. ByHeart initially recalled two lots of formula but later expanded the recall to all products, as federal health officials could not rule out contamination of all products made since the company launched in March 2022. Company testing in November had previously found six of 36 formula samples from three different lots contained the dangerous bacteria.
Food safety experts described illnesses caused by botulism bacteria in infant formula as rare and the ByHeart outbreak as unprecedented in its size and scope. Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, advocated for mandatory testing of raw materials and finished formula. Bill Marler, a food safety lawyer representing over 30 families of sickened babies, stated that the company remains responsible for the harm caused by its product, even if the contamination is traced to a milk supplier.
ByHeart, which previously accounted for about 1% of the U.S. infant formula market, sold approximately 200,000 cans per month. The formula was marketed as being close to human breast milk, using "organic, grass-fed whole milk," and cost about $42 per can.