Overview
- At least 15 infants in 12 states have been hospitalized with confirmed botulism linked to ByHeart products, and no deaths have been reported.
- ByHeart expanded an initial two-lot action to a nationwide recall of all powdered formula and granted the FDA unrestricted access to its facilities.
- The FDA inspected the company this week and reported that testing confirmed a botulism pathogen in a ByHeart bottle, with additional lab and tracing work ongoing.
- Health officials urge parents to stop using ByHeart formula, document lot numbers, clean feeding equipment, and seek immediate care if symptoms such as poor feeding, weak cry, or breathing trouble develop.
- Two Texas infants received antibody treatment, and a lawyer says families face substantial medical bills as at least two lawsuits have been filed.