Probiotics for Infants
A Documented FDA Action, and a Death
Evidence grade 2 of 5, Thin. Read how the Atlas grades evidence.
Evidence is strongly indication-specific and does not support a single blanket grade, so the recommended value sits at 2 to reflect the mixed and population-limited picture, with the per-indication reality spelled out here. STRONGEST (moderate, grade 3): Lactobacillus reuteri DSM 17938 is associated with reduced crying specifically in BREASTFED infants with colic. The 2018 Pediatrics individual-participant-data meta-analysis (Sung and colleagues, 345 infants) found a day-21 benefit in breastfed infants and insufficient data to conclude benefit for formula-fed infants, so the effect is modest and does not generalize. Probiotics (Lactobacillus rhamnosus GG or Saccharomyces boulardii) reducing antibiotic-associated diarrhea in children is also moderate: the 2019 Cochrane review (33 trials, 6,352 children) found roughly 8 percent versus 19 percent, and ESPGHAN gives a conditional recommendation. MIXED and NOT endorsed for routine use (grade 2): probiotics associated with lower necrotizing enterocolitis in preterm infants carry low-certainty ratings in the 2023 Cochrane review, and the 2021 AAP clinical report recommends AGAINST routine universal administration, especially under 1,000 g, citing inconsistent safety and efficacy data and the absence of an FDA-approved pharmaceutical-grade product. PREVENTION of eczema and allergy is mixed and not a settled recommendation. Across all uses, no probiotic is FDA-approved for infants of any age and retail products are sold as supplements, not evaluated to drug standards.
- FDA
- FDA has NOT approved any probiotic for infants of any age; 2023 warning letters issued
- WADA
- Not prohibited
Reference only. Not medical advice.
What can go wrong
This is a pediatric topic where the two settings carry very different risk. In the NICU, the FDA warns that microorganisms in probiotics can cause invasive, potentially fatal bacterial or fungal infections in very preterm or very low birthweight infants; a 2023 preterm death was genetically matched to a probiotic product. These products were used to try to prevent necrotizing enterocolitis, itself dangerous, so the risk-benefit judgment is genuinely complex and belongs entirely to the neonatology team, with informed discussion with the family. For otherwise healthy full-term infants and the general consumer, the facts are simpler: no probiotic is FDA-approved for infants of any age, these products are sold as supplements rather than evaluated to drug standards, product contents do not always match label claims, and a colic benefit is at best modest and limited to breastfed infants. Ēnel does not provide strains, doses, or a how-to. Any consideration of an infant probiotic, for colic, for gut health, or in the hospital, should be decided with a pediatrician or neonatologist who knows the specific child.
Probiotics for infants are two very different questions wearing one name. In hospitalized preterm infants, a large body of trials associates certain probiotics with lower rates of necrotizing enterocolitis, a devastating intestinal disease of prematurity, but that is a supervised NICU decision, the certainty is rated low to moderate, and in 2023 the FDA acted after a premature infant died of sepsis genetically matched to a probiotic product. Separately, for otherwise healthy breastfed infants with colic, one strain (Lactobacillus reuteri DSM 17938) is associated with a modest reduction in crying, an effect that has not held up for formula-fed infants. Across the board, no probiotic is FDA-approved for infants of any age, and retail products are sold as supplements, not evaluated to drug standards. This entry keeps the NICU tradeoff and the over-the-counter question strictly separate, and routes every use through a pediatrician or neonatologist.
No probiotic is FDA-approved for infants, and in 2023 a hospital probiotic was genetically linked to a premature infant's fatal infection.
What people take it for
These are the reasons people give for taking it. They are not effects it has been shown to have.
Safety in detail
Safety is context-dependent and not automatic. In very preterm or very low birthweight infants the live organisms in probiotics can cause invasive, potentially fatal bacterial or fungal infection, and a 2023 preterm death was genetically matched to a probiotic product (Evivo with MCT Oil, Bifidobacterium longum sepsis); this NICU risk-benefit judgment belongs entirely to the neonatology team with informed family discussion. Serious infections, including fungemia and sepsis, have also been reported in immunocompromised and critically ill children. No probiotic is FDA-approved for infants of any age, retail products are sold as supplements not evaluated to drug standards, and contents do not always match label claims. Dosing and strain selection are informational and guideline-attributed only, never a personal prescription. Any consideration of an infant probiotic, for colic, gut health, or in the hospital, should be decided with a pediatrician or neonatologist who knows the specific child.
What people get wrong
Often saidProbiotics are gentle and obviously safe for babies.
ActuallyNo probiotic is FDA-approved for infants of any age, and in 2023 the FDA acted after a premature infant died of sepsis genetically matched to a probiotic product (Evivo with MCT Oil). The FDA's health-care-provider letter warns that in very preterm or very low birthweight infants the organisms in probiotics can cause invasive, potentially fatal bacterial or fungal disease. Safety is context-dependent, not automatic.
Often saidIf studies show probiotics prevent NEC, every NICU should give them.
ActuallyThe 2020 Cochrane review associates probiotics with lower necrotizing enterocolitis (RR 0.54, 95% CI 0.46 to 0.65), but rates that finding low certainty and notes trial methods may exaggerate benefit. The 2021 AAP clinical report does not support routine, universal use, especially under 1,000 g, partly because no pharmaceutical-grade product exists in the US and the most rigorous recent trials did not reduce NEC in the highest-risk infants. This is a supervised, case-by-case NICU decision, not a blanket recommendation.
Often saidThe colic probiotic works for all fussy babies.
ActuallyThe 2018 Pediatrics individual-participant-data meta-analysis (Sung and colleagues, 345 infants) found L. reuteri DSM 17938 reduced crying only in BREASTFED infants (day-21 adjusted mean difference minus 25.4 minutes) and reported insufficient data to conclude any benefit for formula-fed infants. The effect is modest and population-specific, not universal.
Often saidThe 2023 recall means Similac formula is dangerous.
ActuallyThe FDA actions concerned specific hospital probiotic products (Evivo with MCT Oil and Similac Probiotic Tri-Blind), not retail Similac infant formula, which the FDA said parents can continue to use. The core issue is the lack of approval and a documented harm in preterm infants, not a formula recall.
Who profits, and who pushes back
US FDA (Dr. Peter Marks, CBER)
Products containing live microorganisms may present serious risks to preterm infants in hospital settings; the FDA has not approved any probiotic product for use as a drug or biological product in infants.
FDA warning letter to Infinant Health
A preterm infant given Evivo with MCT Oil developed sepsis caused by Bifidobacterium longum and died; genomic sequencing data demonstrate the bacterium was a genetic match to the bacteria in the probiotic.
FDA warning letter to Abbott
Similac Probiotic Tri-Blend is an unapproved new drug and unlicensed biological product; the company agreed to discontinue sales and recalled the product.
Neonatology context
Probiotics were used to try to prevent necrotizing enterocolitis, which affects up to 9,000 infants a year with a roughly 50% death rate, so the NICU risk-benefit decision is genuinely complex and clinician-led.
Where the research comes from
Most of the published research on this comes from one place. 100% of it is from No approved infant probiotic. Findings that no unrelated group has reproduced are weaker than the study count makes them look.
| Place | Share of published research |
|---|---|
| No approved infant probiotic | 100% |
Research published from: US.
How we got here
Necrotizing enterocolitis was recognized in premature newborns across the 20th century, and by the late 1990s neonatal units outside the West began trialing live bacteria to protect the immature preterm gut, with a 1999 Bogota trial by Hoyos in Colombia reporting lower NEC rates and Asian and European NICUs following. Infant colic research took a separate path after Savino and colleagues in Turin reported in 2007 that Lactobacillus reuteri reduced crying, launching a decade of replication that culminated in the 2018 Sung individual-participant-data meta-analysis narrowing the benefit to breastfed infants. Cochrane pooled the preterm trials over the 2010s and 2020s while rating certainty low, and in 2021 the American Academy of Pediatrics declined to endorse routine use. In September 2023, after a preterm infant died of sepsis genetically matched to Evivo with MCT Oil, the FDA issued a Dear Health Care Provider letter and warning letters, drawing the sharpest US regulatory line on the topic to date.
Necrotizing enterocolitis was described in premature newborns through the 20th century, and by the 1990s and 2000s neonatal units in Colombia, Japan, Italy, and elsewhere began trialing live bacteria to protect the immature preterm gut, well before the practice drew wide Western attention. A landmark 1999 Bogota trial by Hoyos in Colombia reported lower necrotizing enterocolitis rates with a Lactobacillus and Bifidobacterium supplement, and Asian and European NICUs followed with their own trials. Colic research took a separate path: Italian investigators (Savino and colleagues, Turin) reported in 2007 that Lactobacillus reuteri reduced infant crying, launching a decade of replication. By 2020 Cochrane had pooled dozens of preterm trials, and in 2021 the American Academy of Pediatrics declined to endorse routine use. In 2023, after a preterm infant's death, the FDA issued warning letters and product recalls, marking the sharpest US regulatory line drawn on the topic to date.
- 1999Hoyos publishes a Bogota, Colombia NICU trial associating a Lactobacillus/Bifidobacterium supplement with lower necrotizing enterocolitis rates in preterm infants
- 2007Savino and colleagues (Turin, Italy) report Lactobacillus reuteri reduced crying in breastfed colicky infants, opening a decade of colic trials
- 2018Sung and colleagues publish an individual-participant-data meta-analysis in Pediatrics (4 trials, 345 infants) finding L. reuteri DSM 17938 benefits breastfed, not formula-fed, colicky infants
- 2020Cochrane review (Sharif and colleagues, 60 RCTs, ~11,156 infants) associates probiotics with lower necrotizing enterocolitis (RR 0.54) and mortality (RR 0.77), rated low-to-moderate certainty
- Jun 2021AAP clinical report (Poindexter and the Committee on Fetus and Newborn) states current evidence does not support routine, universal probiotic use in preterm infants, especially under 1,000 g
- Sep 28, 2023FDA warns Infinant Health over Evivo with MCT Oil after a preterm infant (birthweight under 1,000 g) died of Bifidobacterium longum sepsis genetically matched to the product; product recalled
- Sep 29, 2023FDA issues a health-care-provider letter warning that probiotics can cause invasive, potentially fatal disease in preterm infants
- Oct 24, 2023FDA warns Abbott over Similac Probiotic Tri-Blind; Abbott discontinues and recalls the product (about 226,000 packets)
- 2018-2023More than two dozen adverse events reported to the FDA in connection with infant probiotic products
At a glance
- FDA-approved infant probiotic
- None
- Infant death
- 1 (2023, sepsis)
- Adverse events since 2018
- 2+ dozen
- Products recalled
- Evivo w/ MCT Oil; Similac Tri-Blend
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about Probiotics for Infants. A short entry is not a safe entry.
- Cost and market. We have not documented what it sells for or who sells it.
- Supply chain. We have not mapped where it is made.
- Who uses it. We have not documented the user groups.
- What could change. No forward-looking summary yet.
- How it compares. We have not set it against the alternatives.
- Children and teenagers. We have not checked what is known about younger people.
Sources
FDA raised concerns in 2023 about probiotic products sold for hospitalized preterm infants after an infant given Evivo with MCT Oil developed Bifidobacterium longum sepsis and died, confirmed by genetic sequencing, with warning letters issued and no probiotic FDA-approved for infants.
FDA Dear Health Care Provider letter warns that preterm infants given probiotics are at risk of invasive, potentially fatal bacterial or fungal disease, and describes the fatal Evivo case and over two dozen adverse events reported since 2018.
FDA, Warning Regarding Use of Probiotics in Preterm Infants (DHCP letter)
The AAP 2021 clinical report recommends against routine administration of probiotics to preterm infants, particularly those under 1,000 g, citing inconsistent safety and efficacy data and the absence of an FDA-approved pharmaceutical-grade product, and advises informed parental consent.
American Academy of Pediatrics, Use of Probiotics in Preterm Infants (Pediatrics, June 2021)
Individual-participant-data meta-analysis found L. reuteri DSM 17938 reduced crying and fussing in breastfed infants with colic, with insufficient data to conclude any benefit in formula-fed infants.
Sung and colleagues, Pediatrics, Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis
Cochrane review of probiotics for prevention of necrotizing enterocolitis in preterm infants reports an association with lower NEC but rates the certainty of evidence low and notes trial limitations.
Cochrane review found probiotics reduce antibiotic-associated diarrhea in children (about 8 percent versus 19 percent across 33 trials and 6,352 children), with Lactobacillus rhamnosus and Saccharomyces boulardii the best-studied.
Cochrane, Probiotics for the prevention of antibiotic-associated diarrhea in children
ESPGHAN gives a conditional recommendation for Lactobacillus rhamnosus GG or Saccharomyces boulardii at high doses to prevent antibiotic-associated diarrhea in children, reflecting moderate certainty and cautious framing.
ESPGHAN Working Group, Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children
FDA safety communication on risk of invasive disease in preterm infants given probiotics formulated to contain live bacteria or yeast, summarizing the adverse events and the fatal case.
FDA safety information / news release on probiotics in preterm infants
Independent reporting confirming the 2023 FDA warning followed one infant death linked to a probiotic given in a hospital, with genetic sequencing matching the organism to the product.
CNN Health, coverage of FDA probiotic warning after infant death