Investing.com -- The U.S. Food and Drug Administration has issued warning letters to Target, Walmart, Kroger, and Albertsons for continuing to sell recalled ByHeart infant formula linked to a botulism outbreak.
The FDA released the letters on Monday, dated December 12, directing the retailers to improve their efforts to remove the recalled products from store shelves. According to the Centers for Disease Control and Prevention, 51 babies who consumed ByHeart formula have been hospitalized for botulism, though none have died.
ByHeart initially recalled some formula lots on November 8, then expanded the recall to all of its inventory on November 11. Despite these notifications, FDA investigators and state partners found the recalled formula remained available for purchase at multiple store locations across numerous states well after the recall was initiated.
The FDA letters detail that Target had recalled formula on shelves in at least 20 states, Walmart in 21 states, Kroger in 10 states, and Albertsons in 11 states. In one instance, Arkansas state partners observed ByHeart formula single-serve packs on a Target store shelf with promotional "Sale!" signage offering a $2.00 discount days after the recall was announced.
Store associates offered various explanations for the continued presence of recalled products, including lack of awareness of the recall notice, confusion about which lots were affected, failure to remove all impacted products, and stocking items that arrived after the recall notification.
The FDA also criticized Walmart, Kroger, and Albertsons for failing to respond to follow-up emails requesting information about their plans to address the situation. The letters give the companies 15 working days to respond with specific steps they have taken to address the violations.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
