ByHeart recalls all infant formula nationwide
ByHeart expanded its recall Tuesday to all of its infant formula products nationwide amid an infant botulism outbreak, with at least 15 babies in 12 states hospitalized since August and FDA data indicating the brand is overrepresented among cases despite holding about 1% of U.S. sales. The company told parents to stop using and dispose of ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches; products are sold online and at retailers including Target, Walmart, and Whole Foods that serve Twin Cities shoppers, and FDA inspectors are on site at a canning facility in Portland, OR.
Health
Public Safety
đ Key Facts
- Recall expanded Nov. 11, 2025 to all ByHeart infant formula products
- At least 15 infants in 12 states hospitalized; FDA probing 84 cases since August
- FDA: Over one-third of formula-related cases involved ByHeart, which has ~1% market share