FDA Raises Concerns About Infant Probiotic Products Sold by 2 Companies to Treat Preterm Babies in Hospitals. Products Recalled Since. | Food Recalls & Alerts
More than 24 babies reported sick since 2018 and 1 dead in 2023. Affected probiotics, sold by 2 companies, contain live microorganisms and unapproved ingredients which don't meet the safety requirements for infants. The products were promptly recalled after receiving FDA warning letters. Products were sold to hospital use nationwide.
Who's At Risk?
Preterm babies are vulnerable to infections and sepsis when ingesting probiotics because of their permeable intestinal linings (leaky guts).
Symptoms
Invasive, potentially fatal disease (sepsis) caused by the bacteria or fungi contained in the probiotics