Analysis of the U.S. Infant Formula Botulism Outbreak
On November 8, 2025, the U.S. Food and Drug Administration (FDA) issued a recall notice, stating that ByHeart Inc. was recalling two batches of complete nutrition infant formula due to the potential risk of causing botulism in infants. On November 11, the U.S. FDA further expanded the recall scope to include all infant formula products under the ByHeart brand. As of November 19, 2025, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states.