{"id":36092,"date":"2026-01-23T20:52:58","date_gmt":"2026-01-24T02:52:58","guid":{"rendered":"https:\/\/citystuff.com\/chicago\/2026\/01\/23\/tests-reveal-powdered-milk-may-be-cause-of-byheart-botulism-outbreak-nbc-chicago\/"},"modified":"2026-01-23T20:52:59","modified_gmt":"2026-01-24T02:52:59","slug":"tests-reveal-powdered-milk-may-be-cause-of-byheart-botulism-outbreak-nbc-chicago","status":"publish","type":"post","link":"https:\/\/citystuff.com\/chicago\/2026\/01\/23\/tests-reveal-powdered-milk-may-be-cause-of-byheart-botulism-outbreak-nbc-chicago\/","title":{"rendered":"Tests reveal powdered milk may be cause of ByHeart botulism outbreak \u2013 NBC Chicago"},"content":{"rendered":"

Introduction to the Outbreak<\/h2>\n

Powdered whole milk used to make ByHeart infant formula could be a source of contamination that led to an outbreak of botulism that has sickened dozens of babies, U.S. health officials indicated Friday.
\nTesting by the U.S. Food and Drug Administration found the type of bacteria that can cause the illness in two samples linked to the formula, officials said.
\nThe agency found that bacteria in an unopened can of formula matched a sample from a sick baby \u2014 and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company.
\nFDA testing also found contamination in a sample of whole milk powder supplied to ByHeart \u2014 and it matched the germ in a finished sample of the company’s formula.<\/p>\n

Investigation and Findings<\/h2>\n

The findings are not conclusive, and the investigation continues \u201cto determine the source of the contamination,\u201d the agency said in a statement.
\nA ByHeart official said the finding helps shed light on what has become a \u201cwatershed moment\u201d for the company.
\n\u201cWe are focused on the root cause and our responsibility to act on what we\u2019ve learned to help create a safer future for ByHeart and infant formula," said Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer.
\nNeither FDA nor ByHeart named the supplier of the powdered whole milk.
\nAt this time, there is no indication of a broader problem in the infant formula supply, the FDA said.<\/p>\n

The Outbreak and Its Impact<\/h2>\n

New York-based ByHeart has been at the center of a food poisoning outbreak that has sickened 51 babies in 19 states since December 2023.
\nThe problem was identified in November after officials with the California program that supplies the sole treatment for infant botulism detected a surge in cases in babies who consumed ByHeart formula.
\nNo new cases in the outbreak have been identified since mid-December, the U.S. Centers for Disease Control and Prevention said.
\nByHeart initially recalled two lots of formula, but it expanded the recall to all products days later.
\nFederal health officials later said they could not rule out contamination of all products made since the company launched in March 2022.<\/p>\n

Regulatory Response and Safety Measures<\/h2>\n

That followed company testing, announced in November, that found six of 36 samples of formula from three different lots contained the dangerous type of bacteria that causes infant botulism.
\nIllnesses caused by botulism bacteria in infant formula are rare, and the size and scope of the ByHeart outbreak is unprecedented, food safety experts said.
\nSome formula companies do test raw materials and finished formula for evidence of the contamination, but such testing should be required, said Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, an advocacy group.
\n\u201cFDA has not announced a plan to do testing, and that’s what we really want to see them do,\u201d she said.
\nEven if the contamination was traced to a milk supplier, the company remains responsible for the harm caused by its product, said Bill Marler, a Seattle food safety lawyer who represents more than 30 families of babies who fell ill.
\n\u201cJust because they are able to point the finger at dried powder as the ingredient that may have been contaminated, it doesn\u2019t take any of the legal or moral responsibility away from ByHeart,\u201d Marler said.<\/p>\n

Company and Product Background<\/h2>\n

ByHeart, which accounted for about 1% of the U.S. infant formula market, previously sold about 200,000 cans of the product per month.
\nIt was marketed as an option close to human breast milk, one that used \u201corganic, grass-fed whole milk.\u201d
\nParents of babies sickened in the outbreak said they chose the formula, which cost about $42 per can, because of its touted health benefits.
\nBotulism is a rare but severe illness that attacks the nerves in the body.<\/p>\n

Conclusion<\/h2>\n

The discovery of potential contamination in powdered whole milk used by ByHeart highlights the importance of rigorous testing and quality control in the production of infant formula. As the investigation continues, it is crucial for regulatory agencies, manufacturers, and consumers to work together to ensure the safety of these critical nutrition products for infants.<\/p>\n

FAQs<\/h2>\n