The U.S. Food and Drug Administration (FDA) issued a stern warning letter to The Kroger Co. for failing to remove recalled ByHeart Whole Nutrition Infant Formula from its store shelves. The recall is linked to a multistate infant botulism outbreak, which the CDC called "unprecedented."
The FDA released the letter Monday, stating the recalled formula remained on shelves at Kroger locations across 10 states. This occurred for several days after the company was initially notified.
The agency criticized Kroger’s response as inadequate. The company failed to provide sufficient information on corrective actions despite multiple follow-up communications. The FDA warned that failure to address the matter could result in legal action, including seizure and injunction.