Expanding Recalls and Increased Transparency: The Potential Consequences of New FDA Policies in an Infant Formula Recall

On Dec. 10, 2025, the FDA announced that, as a result of the ongoing investigations into the contamination of ByHeart infant formula, the Centers for Disease Control expanded the case definition to include any infant diagnosed with botulism who was exposed to ByHeart formula since the product was released in March 2022….
By: McGuireWoods LLP