The number of infants sickened by botulism linked to contaminated formula has increased, according to the U.S. Centers for Disease Control and Prevention.
As of Dec. 10, 2025, there have been 51 cases of infant botulism, the CDC said, with all 51 babies hospitalized. The cases have been reported in 19 states, including Pennsylvania.
The U.S. Food and Drug Administration said previous case counts included illnesses from Aug. 1, 2025. The current case count includes 10 from Dec. 2023 through July 2025 that the FDA described as "confirmed infant botulism cases with documented exposure to ByHeart formula."
The infants range in age from about 2 weeks to 9 months old.
No deaths have been reported.
The outbreak has been linked to ByHeart Whole Nutrition formula, which was recalled by the

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