Analysis of the Cronobacter sakazakii outbreak in baby formula in the United States

Published 2025년 11월 17일

Tridge summary

Core Alert: On November 8, 2025, the U.S. Food and Drug Administration (FDA) issued a recall announcement, with ByHeart Inc. recalling two batches of its full-nutrition infant formula due to a potential risk of infant botulism. On November 11, the U.S. FDA further expanded the recall scope and issued an expanded recall announcement, including all ByHeart brand infant formula products. On the same day, the U.S. Centers for Disease Control and Prevention (CDC) announced that the botulism outbreak related to ByHeart brand infant formula has resulted in 15 people falling ill in 12 states. Food Partners Network conducted an analysis of this outbreak.

Original content

One, Botulinum: The Hidden "Health Killer" Botulinum (Clostridium botulinum), also known as botulinum bacillus, is widely distributed in soil, marine and lake sediments, and livestock manure. In an anaerobic environment, botulinum can produce a potent exotoxin, botulinum toxin, which is the "culprit" that causes poisoning in humans. The intestinal flora of infants and young children (especially those under one year old) has not yet fully developed, and their intestinal barrier function is weak. If they consume food containing botulinum spores, the spores will proliferate in the intestines of infants and young children and produce toxins, which, once absorbed, cause poisoning. Affected infants may exhibit symptoms such as constipation, poor feeding, ptosis (drooping of the eyelid), delayed pupillary response, low muscle tone, difficulty in sucking and swallowing, general weakness, difficulty breathing, and even sudden respiratory arrest. It is worth noting that botulinum is ...

Source: Foodmate