ByHeart faces growing scrutiny after tests found bacteria capable of causing botulism in its infant formula. A third-party lab in Washington state detected the contamination, prompting the company to alert the US Food and Drug Administration immediately. US health officials reported that the number of hospitalised babies linked to the outbreak has risen to 31, up from 23 last week.
The FDA said the cases stretch across 15 states, with the earliest reported illness dating back to August 9. As the situation escalates, ByHeart continues investigations to trace the source and prevent another breakdown in product safety. The company stated that it aims to protect families and keep them fully informed.
ByHeart initially recalled two lots on November 8 but expanded the recall nationwide only three days later. Despite the alerts, officials still found some recalled cans on store shelves, raising concerns about retailer compliance. The FDA stressed that no ByHeart products should remain available in stores or online. It also urged international buyers to stop using formula purchased through online sellers.
FDA Commissioner Marty Makary said the agency is moving quickly and firmly and that no child should become sick because of slow action. ByHeart grew popular during the 2022 formula shortage, though it represents only 1% of US formula sales.
