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Key points CDC and public health officials in several states, the Infant Botulism Treatment and Prevention Program, and FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula. Recalled food On November 8, 2025, ByHeart Inc. recalled two lots of Whole Nutrition Infant Formula: Lot: 206VABP/251261P2 (Use by 01 Dec 2026") Lot: 206VABP/251131P2 ("Use by 01 Dec 2026") ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide. FDA reports that ByHeart Whole Nutrition Infant Formula makes up an estimated 1% of all infant formula sales in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers. Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms: Poor feeding Loss of head control Difficulty swallowing Decreased facial expression Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots of infant formula."