Baby botulism outbreak: FDA still doesn't know cause—or how to prevent it
Summary
The FDA investigated a baby botulism outbreak linked to contaminated infant formula made by ByHeart but has not found the exact source or how to prevent future cases. The outbreak infected 48 babies across 17 states, and companies involved are blaming each other without accepting clear responsibility.Key Facts
- The botulism outbreak started in early November and ended in late February.
- 48 infants were sickened and hospitalized; some are still recovering.
- The bacteria, Clostridium botulinum, produces spores found in soil that can cause severe paralysis in babies.
- The contaminated formula came from ByHeart and was linked to powdered milk from Organic West and a Dairy Farmers of America facility.
- The FDA traced the contamination to specific milk powder lots but couldn’t find where or how spores entered the supply.
- ByHeart, Organic West, and Dairy Farmers of America each deny responsibility.
- A food poisoning lawyer representing some families says the FDA’s findings are incomplete and believes ByHeart is ultimately responsible for product safety.
- This is not the first time infant formula has been linked to botulism outbreaks.
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