U.S. Reports Increase in Infant Botulism Cases
Epidemiological analysis and laboratory findings suggest ByHeart Whole Nutrition infant formula contains Clostridium botulinum bacteria, triggering widespread illness among babies throughout multiple American regions, the FDA confirmed.
Illness onset among affected infants occurred between Aug. 9 and Nov. 19. The 39 hospitalized children—ranging from approximately 2 weeks to roughly 9 months old—have all survived, with zero fatalities reported to date.
Every infant afflicted had consumed ByHeart Whole Nutrition powdered formula prior to developing symptoms, federal investigators determined.
The comprehensive recall encompasses all ByHeart products, including every lot number of formula cans and single-serve stick packets currently in circulation.
The FDA acknowledged persistent challenges with recall implementation, noting that "it continues to receive reports of recalled products still appearing on grocery store shelves." The agency emphasized its collaboration with state authorities and retail chains "to ensure the recall is effective and that all affected products are immediately removed from shelves nationwide."
Federal investigators continue probing the contamination's origin and entry point into the manufacturing process.
According to FDA guidance, initial infant botulism indicators include constipation, feeding difficulties, diminished head control, and swallowing complications. Advanced cases may progress to respiratory distress and potentially life-threatening respiratory arrest, the agency warned.
Parents and caregivers should immediately discontinue use of any ByHeart formula products and consult pediatricians if infants exhibit warning signs.
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