A voluntary recall linked to over a dozen cases of infant botulism has now expanded. In a news release on Tuesday, Nov. 11, ByHeart Whole Nutrition Infant Formula announced that it is expanding its ...

The Food and Drug Administration has sent out warning letters to multiple retailers after stores failed to remove recalled baby formula linked to an outbreak of infant botulism from the shelves.

Update: On Dec. 10, 2025, the FDA expanded the ByHeart recall to include all formula the company has ever produced. If you have ByHeart Whole Nutrition infant formula, stop using it immediately.

The Food and Drug Administration has warned four major retailers that they failed to meet statutory requirements to make sure their stores removed ByHeart infant formula after it was recalled. The ...