At least 106 people have been infected by the outbreak strain in 13 European countries. Young people are disproportionately affected. Some sickened children reported eating the noodles and seasoning dry, without adding boiling water as instructed on the package.
Traceability investigations identified a common seed supplier, with implicated alfalfa seeds imported from India and distributed throughout Europe. Available evidence suggested the seeds were likely contaminated before entering the EU.
ByHeart-commissioned research shows the currently accepted “gold standard” for Clostridium botulinum detection in powdered formula, SRC enumeration, may fail to catch contamination. It is used by many formula brands, including Nara Organics, another company linked to an infant botulism outbreak. Following this finding, third-party IEH Labs developed a novel detection method.
For a time, ByHeart Nutrition and Nara Organics both used Organic West milk dried by Dairy Farmers of America in their infant formula products (confirmed by Food Fix). Both brands have been implicated in botulism outbreaks that occurred within months of each other.
Between 2015 and 2024, the German Federal Office of Consumer Protection and Food Safety (BVL) and the Robert Koch Institute investigated 3,021 foodborne illness outbreaks.
New ByHeart-commissioned research suggests that sulfite-reducing clostridia (SRC) enumeration, the “gold-standard” test for C. botulinum in powdered infant formula, which was used by Nara Organics prior to the ongoing outbreak, is insufficient. Experts who spoke to Food Safety Magazine agree C. botulinum should be considered as a foreseeable hazard requiring specific preventive controls.
Three babies in three states have been sickened in the second infant botulism outbreak identified since late-2025. All patients were fed Nara Organics Whole Milk Infant Formula. A recall has been issued, and product testing is underway.
The now-recalled requeson cheese was produced by Maryland-based Clover Hill Dairy. Patients have been identified in New York, Maryland, and Virginia, with the earliest illness occurring in early 2023 and the most recent in May 2026.
FDA did not identify deficiencies in ByHeart’s production facilities that could explain the outbreak, but a powdered milk ingredient did test positive for C. botulinum. ByHeart is developing an action plan based on data generated from the investigations.
The latest data from the UK Health Security Agency (UKHSA) show that the number of Campylobacter and Salmonella infections in England remained high or increased in 2025, while listeriosis cases stayed stable from the previous year.
