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Walmart was warned about failing to remove ByHeart Whole Nutrition Infant Formula from store shelves despite receiving written recall notifications from the manufacturer on November 8 and November 11, 2025, related to contamination with Clostridium botulinum. The recalled formula was found available for purchase in at least multiple Walmart locations across 21 states well after the recall was initiated and expanded to all unexpired lots. This noncompliance rendered the products adulterated under the Federal Food, Drug, and Cosmetic Act as they contained a poisonous substance that could injure infant health, resulting in a multistate outbreak affecting 51 infants across 19 states as of December 10, 2025.