Federal health officials on Wednesday expanded the outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since March 2022. The U.S. Food and Drug Administration (FDA) stated it 'cannot rule out the possibility that contamination might have affected all ByHeart formula products' ever made.
This outbreak now includes at least 51 infants across 19 states, with the most recent case reported on December 1. The CDC has defined this outbreak to include any infant exposed to ByHeart formula since the product's initial release.
No deaths have been reported thus far, but the rise in botulism cases had previously led health officials to identify 39 suspected or confirmed cases reported in 18 states, starting as early as August 2023. Following revised definitions, the CDC has identified 10 additional cases that transpired between December 2023 and July 2025.
ByHeart, a New York-based producer of organic infant formula, recalled all its products sold in the U.S. as of November 11. Previously accounting for about 1% of the U.S. formula market, the company had been selling around 200,000 cans of its formula monthly.
The news has distressed parents. Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized with infant botulism, expressed shock and concern at the potential long-standing contamination. 'They really need to be held accountable,' she stated, reflecting widespread parental fears.
The FDA has recently inspected ByHeart's production plants in Iowa and Oregon, but results from these inspections have not yet been made public. Initial tests revealed that 36 samples from three different lots of ByHeart formula contained the bacteria linked to infant botulism.
Regulatory scrutiny is heightened due to ByHeart’s history of contamination issues, including prior recalls for other bacterial contaminations and complaints received concerning their manufacturing practices.
While infant botulism remains rare, affecting fewer than 200 infants annually in the U.S., the implications for affected families are severe. Symptoms generally manifest within 30 days and can involve serious neurological damage. Current treatment involves BabyBIG, a medication derived from the blood plasma of individuals immunized against botulism.
Given the alarming circumstances, many families have initiated lawsuits against ByHeart, claiming negligence and seeking compensation for medical expenses and emotional distress. The situation underscores pressing concerns regarding food safety standards in the U.S. infant nutrition market.
