FDA WARNING_LETTER - The Kroger Company - November 19, 2025

The U.S. Food and Drug Administration issued a Warning Letter to The Kroger Company on December 12, 2025, regarding significant violations related to a multistate infant botulism outbreak. An investigation, which began in November 2025, linked ByHeart Whole Nutrition Infant Formula to 51 infant botulism cases. ByHeart initiated a voluntary recall of the formula on November 8, 2025, which expanded on November 11, 2025. Despite these notifications, FDA and state partners observed recalled formula still available for purchase in multiple Kroger, King Sooper’s, and Smith’s stores across 10 states between November 12 and November 19, 2025. This continued sale of adulterated food, which contained Clostridium botulinum and could be injurious to health, violates sections 402(a)(1) and 301(c) of the Federal Food, Drug, and Cosmetic Act. Kroger store associates offered various explanations for the oversight, including lack of recall awareness. The FDA held a call with Kroger"s CEO on November 19, 2025, requesting information on corrective actions, but as of December 8, 2025, Kroger had not provided the requested documentation. Kroger is required to respond within 15 working days, detailing specific steps taken to correct the violations, prevent recurrence, and provide supporting documentation. Failure to comply may lead to legal action.