FDA WARNING_LETTER - The Albertsons Companies Incorporated - November 19, 2025

The U.S. Food and Drug Administration issued a Warning Letter to The Albertsons Companies Incorporated on December 12, 2025, following an investigation initiated in November 2025 into a multistate infant botulism outbreak. The outbreak, linked to ByHeart Whole Nutrition Infant Formula, affected 51 infants across 19 states due to the presence of Clostridium botulinum, rendering the product adulterated. The primary violation cited was Albertsons" failure to effectively implement the voluntary recall of this formula. Despite receiving recall notifications on November 8 and November 11, 2025, FDA and state partners confirmed the recalled product remained available for purchase in multiple Albertsons stores across 11 states as late as November 19, 2025. This continued sale of adulterated food constitutes a violation of sections 402(a)(1) and 301(c) of the Federal Food, Drug, and Cosmetic Act. Explanations for the ineffectiveness included lack of awareness and confusion. The FDA requested information on corrective actions but received no documentation by the letter date. Albertsons is required to investigate the causes of these violations, prevent recurrence, and provide the FDA with a written response detailing specific corrective steps and supporting documentation within 15 working days to avoid potential legal action.