When makers of infant formula learn that babies have become seriously ill or died after using their products, federal regulations require them to notify the FDA. But in a major investigative finding published July 2, 2026, KFF Health News revealed that the FDA has no record of a single such notification from any formula manufacturer going back more than 26 years.
That gap in the federal safety record is not because premature infants haven't died. According to a KFF Health News analysis of federal data, approximately 2,300 newborns died from necrotizing enterocolitis (NEC) in the United States between 2017 and 2023 — roughly one per day. A wave of more than 1,700 lawsuits has alleged that formula made by Abbott (Similac) and Mead Johnson (Enfamil) caused or contributed to these deaths by triggering NEC in premature infants, and that manufacturers knew about the elevated risk without adequately warning parents or physicians.
