FDA Warns Major Retailers, Target Stores Sold Recalled Infant Formula

The Food and Drug Administration notified four large U.S. retailers on December 12 that inspectors found recalled ByHeart infant formula still being sold in stores after the company expanded a recall connected to an outbreak of infant botulism. The agency posted warning letters online and gave each retailer 15 working days to respond and provide evidence of corrective actions taken to remove the product and prevent further sales.

FDA and state and local inspection notes cite multiple instances of recalled ByHeart product available at Target locations across roughly 20 states after the recall notice and after retailers had been notified. The agency flagged a sale at a New Hampshire Target store on November 16 despite an electronic sales block intended to prevent purchases. Inspectors also described a Target store in Arkansas where single serve packs were observed promoted with a discount after the recall took effect.

Federal and state public health officials expanded the outbreak case definition in December and the Centers for Disease Control and Prevention reported dozens of infants hospitalized in connection with ByHeart products. The FDA said it inspected ByHeart facilities and is conducting an investigation, while its letters to retailers focused on the responsibilities of supply chain participants to promptly remove recalled product and document corrective actions.

Retailers told the agency they had taken steps such as blocking product codes, issuing store level removal guidance and offering refunds, but the FDA said the documentation of corrective actions was not provided in the form requested. Inspection notes described store employees giving varied explanations for why recalled product remained on shelves, a sign of confusion about which lots were affected and how to handle incoming deliveries.

For Target employees this episode could mean increased scrutiny at the store level, additional training, inventory audits and more time spent fielding customer questions and processing returns. The inspection findings point to potential gaps in recall communication, inventory control and in store procedures that affect frontline workers and managers who handle product verification and disposal. With retailers required to respond to the FDA in the near term, stores may implement new checks and documentation practices that will affect day to day operations and staffing priorities.