Infant Formula

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Las agencias investigan un brote. Causa: Botulismo (Clostridium botulinum).

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FDA CORE outbreak investigation #1350 (Closed; outbreak ended): Clostridium botulinum; product: Infant Formula 48 cases; 48 hospitalized; 0 deaths; states: AZ, CA, ID, IL, KY, MA, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI; recall initiated (see advisory); FDA traceback, inspection, sampling initiated; recalling firms: ByHeart Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) As part of FDA’s investigation, FDA has completed its on-site inspections of ByHeart facilities. These inspections led to the identification of Clostridium botulinum in a powdered milk ingredient. These inspections did not identify any additional factors within ByHeart’s facilities that could explain the cause of this outbreak. FDA’s root cause investigation is ongoing and will continue with a focus on ingredients. Please see Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula for more information about FDA’s ongoing effo