Botulism Outbreak Expands to All ByHeart Baby Products

Federal health officials have expanded an outbreak of infant botulism linked to ByHeart baby formula to include all products made since the company began production in March 2022. The U.S. Food and Drug Administration has indicated that contamination could potentially affect all ByHeart formula products ever made, with at least 51 infants across 19 states affected.

The outbreak was announced on November 8, and the most recent illness was reported on December 1. Previously, health officials had identified 39 cases of suspected or confirmed infant botulism since August.

ByHeart recalled all its U.S. products on November 11, with the company accounting for about 1% of the U.S. infant formula market. Reports indicate that some infants, like 5-week-old Rowan Galindo, were hospitalized after consuming the formula, raising serious health concerns among parents.

ByHeart has cooperated with federal investigations, which revealed that lab tests showed contamination in samples from different lots. The contamination appears persistent across production runs and raw material lots.

Additionally, the company has a documented history of contamination issues, including a 2022 recall for cronobacter sakazakii and a 2023 FDA warning about necessary corrective actions. Infant botulism is a rare but serious condition affecting fewer than 200 babies each year in the U.S.

Symptoms can take up to 30 days to develop and may involve severe neurological effects. The sole treatment for the condition is BabyBIG, an IV medication made from the pooled blood plasma of immunized adults.

Lawsuits have already been filed against ByHeart, alleging negligence and seeking compensation for medical expenses and emotional distress.