ByHeart Recalls All Infant Formula
Analysis based on 50 articles · First reported Nov 09, 2025 · Last updated Nov 12, 2025
The recall of ByHeart infant formula due to a botulism outbreak has a negative impact on ByHeart's stock price and reputation. While the event does not pose a risk of national formula shortages, it raises broader concerns about food safety regulations and could lead to increased scrutiny of the infant formula industry by the United States — Food and Drug Administration.
ByHeart, an organic baby formula manufacturer, has expanded its recall to include all of its powdered infant formula products nationwide. This action follows an expanding outbreak of infant botulism that has hospitalized 15 babies across 12 states since August. Preliminary tests by California health officials found the bacteria that produces botulinum toxin in an open can of ByHeart formula. The United States — Food and Drug Administration is investigating 84 infant botulism cases, with ByHeart formula disproportionately represented among sick infants, despite accounting for only 1% of U.S. formula sales. The United States — Centers for Disease Control and Prevention has issued guidance for consumers. In response to the outbreak and broader concerns, Robert F. Kennedy Jr. has directed the United States — Food and Drug Administration to review infant formula ingredients as part of 'Operation Stork Speed'.
Set up alerts, explore entity relationships, search across thousands of events, and build custom intelligence feeds.
Open Dashboard