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Infant Formula Outbreaks: A Catastrophic Safety Failure
29 Apr
Summary
- FDA received a complaint in September 2021; recall was in February 2022.
- Two infant formula outbreaks linked to serious health consequences occurred.
- Federal response to formula contamination has been too slow for families.
Food safety lawyer Bill Marler argues that the federal response to infant formula contamination has been too slow for affected families. He highlighted a catastrophic safety issue within the infant formula industry, citing two significant outbreaks.
The first incident involved Abbott Nutrition in 2022. Despite the FDA receiving a complaint in September 2021, a recall did not occur until February 2022. Internal records from Abbott's Sturgis, Michigan facility documented the destruction of contaminated product, and the FDA had not inspected the plant in two years prior. This outbreak led to four infant illnesses, two deaths, and one other infant illness.
A subsequent outbreak in fall 2025 was linked to ByHeart Whole Nutrition formula. This led to 48 infants being hospitalized across 17 states, all requiring treatment with BabyBIG. Investigations found Clostridium botulinum in ByHeart formula and a powdered milk ingredient. Marler concluded that the United States, as the wealthiest nation, has the capacity to ensure infant formula safety, but the federal government's oversight has been too slow and deferential to the industry.
