AP Photo/Cheyanne Mumphrey

Stephen Dexter holds a container of ByHeart baby formula, which was recently recalled by ByHeart, in Flagstaff, Ariz., on Wednesday, Nov. 12, 2025.

At least four families have sued infant formula maker ByHeart saying their babies contracted botulism from contaminated formula, as the company faces ongoing scrutiny from federal investigators and a separate class action lawsuit filed last week.

In the lawsuits, affected families described harrowing days or weeks in the hospital with their babies, who were placed on IVs and feeding tubes. Many said they had chosen ByHeart’s formula because it contained organic whole milk and minimal additives, making it seem like the healthiest option.

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