FDA Warns Retailers Over ByHeart Recall

The United States — Food and Drug Administration sent warning letters to Walmart, Oracle Corporation, Kroger, and Albertsons for failing to promptly remove recalled ByHeart infant formula from their shelves. Despite a November 11 recall of all ByHeart products due to a botulism outbreak that sickened over 50 babies, these retailers continued to sell the contaminated formula for days or weeks. The United States — Food and Drug Administration criticized the companies for not taking prompt and effective action and for failing to provide evidence of corrective measures. Walmart, Oracle Corporation, Kroger, and Albertsons have 15 working days to respond to the letters, with potential legal action if violations are not corrected. The United States — Centers for Disease Control and Prevention expanded the outbreak investigation to include all babies treated for botulism after consuming ByHeart formula since 2023. The United States — Food and Drug Administration itself faced criticism from Steven Mandernach for being slow to distribute recall information to state and local officials.