Target Corporation – FDA Warning Letter, Nov 20, 2025

The FDA issued a Warning Letter to Target Corporation on December 12, 2025, following observations related to a multi-state infant botulism outbreak linked to ByHeart Whole Nutrition Infant Formula. The outbreak, investigated from November 2025, involved 51 infants and confirmed the formula as adulterated due to the presence of Clostridium botulinum. Target was notified of ByHeart"s voluntary recall on November 8, 2025, and an expanded recall on November 11, 2025. Despite these notifications, regulators observed recalled infant formula still available for purchase in numerous Target stores across 20 states between November 12 and 20, 2025. Issues included a lack of recall awareness among associates, confusion over affected lots, and failure to remove all impacted products. Furthermore, Arkansas state partners observed recalled formula actively promoted with a discount in a Target store. The FDA cited Target for violating sections 402(a)(1) and 301(c) of the Federal Food, Drug, and Cosmetic Act, pertaining to the receipt and delivery of adulterated food. The agency emphasized Target"s responsibility to promptly and effectively remove affected products from sale and distribution. Target failed to provide information on implemented corrective actions despite repeated FDA requests, underscoring the inadequacy of its recall response. The FDA expects Target to implement robust measures to prevent future sales of adulterated products.