Key facts
- The FDA has not determined the root cause of the baby botulism outbreak linked to ByHeart formula.
- The agency's investigation is focusing on ingredients.
- Three companies involved are not publicly taking responsibility for the contamination.
The Food and Drug Administration (FDA) has provided an update regarding the baby botulism outbreak that was linked to spore-contaminated formula produced by ByHeart. Despite the clear tracking of the contamination, the FDA has stated that it still does not know how the bacteria entered the formula or how to prevent such an occurrence in the future. The agency's investigation into the root cause is ongoing and is focusing on ingredients. In the absence of a definitive cause, the three companies at the center of the investigation are reportedly pointing fingers at each other, with none publicly accepting responsibility for the contamination.