One product, one panel, one record.
Ferring Pharmaceuticals (manufactured by Rebiotix, Inc.) REBYOTA (fecal microbiota, live-jslm), 150 mL single-dose rectal suspension — BLA 125739 — label audit
The FDA-approved, roughly $9,000 prescription product discloses zero strains — its identity specification is "Bacteroides Species Growth — Growth Observed" plus a redacted diversity assay — and it is still the only product in this batch whose potency is enforced by a regulator across a 36-month dating period. Disclosure of strain names and evidentiary strength are orthogonal, and this label proves it.
This page is an audit of a label. It records what this product’s panel discloses, what of that could be checked against a primary record, and what could not. The score below ranks this product on that disclosure and on nothing else.
The record this page rests on
- NIH label record
- No NIH Dietary Supplement Label Database record is on file for this product in this teardown.
- Label read on
- The most recent dated artefact behind this page. Labels change; this is how old our reading of it is.
- Cohort
- Addendum — outside the founding denominators Torn down 2026-07-31, after the founding cohort of 27 was frozen, and it is not a dietary supplement — it is an FDA-approved prescription biologic, two regulatory lanes above every SKU in D₂₇. It sits outside every D₂₇ denominator this site publishes and is here as the regulatory ceiling.
- How deep this went
- Full forensic teardown Panel transcribed, every strain designator queried, every certification chased to its issuer’s own register, and the literature behind each marketing claim opened and read.
- What did not survive verification
- Part of this page was refuted or could not be reproduced Three bounded items. First, the wholesale price: "$9,135 per unit effective 3 July 2024" is UNVERIFIED — the primary source is login-gated — and is not recorded as a price here. The two figures that are usable each carry a caveat that may not be detached from them: the $9,000 comes from a Ferring-funded budget-impact analysis with sponsor authorship, and the $9,840.60 is a Medicare payment limit rather than a transaction price. Second, part of the product's own identity specification is unreadable: the diversity assay and several acceptance criteria are redacted as (b)(4) trade secret, so the published specification is incomplete by the regulator's own design. Third, no sex-stratified efficacy finding is asserted in either direction, because the approved labelling presents none. One further item is a finding rather than a gap and must travel with the "0 strains" number: REBYOTA names no strains because it is a donor-derived consortium, so the count is 0 of 0, not 0 of N — categorically different from a supplement with fifteen organisms it could have named and did not. What did survive in full: the licence and every identifier attached to it, read at FDA's own record; the release-versus- stability classification of the CFU range; the 8-week efficacy result and the failed 6-month durability endpoint, both verbatim from the approved label; the 67.2% female safety base; and the 29 October 2025 commercial-retreat statement, quoted from Ferring's own release.
The Label Verifiability Score for this product
No score and no rank
No Label Verifiability Score is published for this product, and none is estimated. A score must rest on at least 50% of the rubric by weight; this record answers 36%, so a number here would present an average of one or two components as a summary of five.
The product stays in the audit and stays on this site. It is listed, unranked, on the label audit, and it is absent from the ranking rather than placed at the bottom of it: an unanswered question is not a bad answer, and ranking it as though it were would be a number about our reach dressed up as a fact about the product.
| Component | Weight | What was counted, and where | Fraction |
|---|---|---|---|
| Strain identity printed on the panel | 0.24 | No organism slot has been transcribed from this panel, so there is nothing to count. | Not answered |
| Per-organism amount printed | 0.20 | No organism slot has been transcribed from this panel, so there is nothing to count. | Not answered |
| What the CFU count is measured against | 0.22 | Potency basis "at-manufacture": CFU figure printed yes, single basis stated yes, basis reaches expiry no — 2 of 3. | 2 / 3 = 0.6667 |
| Printed designators that lead to a human trial | 0.20 | No organism slot has been transcribed from this panel, so there is nothing to count. | Not answered |
| Certification confirmed at the issuer’s own register | 0.14 | 1 claimed certification found on the issuer’s own public register. Read the scope before reading the mark: most certify one narrow property. | 1 / 1 = 1.0000 |
This record answers 36% of the rubric by weight, below the 50% floor a published score requires. Scoring it would present an average of one or two components as a summary of five. Listed, unranked, and the components it did answer are shown above.
The ranking of the 154 products that can be scored is on the home page, with what the score measures and what it does not.
What this label discloses
Everything in this table is what the product itself states — on the printed panel, on the brand’s own page, or in the label record the manufacturer filed. Nothing in it is checked yet; checking is the next section.
| Disclosure | As recorded |
|---|---|
| CFU as printed | Each 150 mL dose contains between 1×10⁸ and 5×10¹⁰ colony forming units (CFU) per mL of fecal microbes including >1×10⁵ CFU/mL of Bacteroides |
| What that count is measured against | At manufacture only |
| Strain designators | None — species only |
| Organism slots transcribed here | 0 — the full panel |
| Marketed as | Unisex |
The Summary Basis for Regulatory Action, Table 2 (REBYOTA DP Specification), lists "Viable Bacterial Count — 1.0×10⁸ CFU/mL to 5.0×10¹⁰ CFU/mL" annotated (R), and the table's own footnote reads "R=used for release, S=used for stability." Read precisely, the labelled CFU range is a RELEASE specification. Potency is separately monitored on stability — "The lots will be tested after 0, 3, 6, 9, 12, 18, 24, and 36 months for potency, the presence of Bacterioides species, and diversity" — but the acceptance criterion printed in the labelling is the release number.
The panel’s own words on potency, verbatim.
The count is stated at time of manufacture only. The panel makes no commitment about what is alive when you swallow it.
The panel names species only, with no strain designator anywhere. A species name is not a claim: the trials in this field are of strains, and a species can contain thousands.
What of that is verifiable
A disclosure is verifiable when a reader can open a record that neither we nor the brand controls and see the same thing. Below is every dated artefact this page rests on. What is absent from this list is not verified, however reasonable it sounds.
- Dated capture of the brand’s own page — fda-rebyota-package-insert-163587 (opens in a new tab) captured Not a brand page — the FDA-hosted package insert, 12 pages, HTTP 200 and machine-readable. The type field's nearest available value is brand-page-capture and this note says what the artefact actually is. Source for §11 DESCRIPTION (the composition statement and the CFU range), §14 (the Bayesian efficacy analysis at 8 weeks and the failed 6-month sustained-response endpoint), §12.1 (mechanism not established), §13 (no nonclinical toxicology), §5.1 and §5.3 (transmissible agents, food allergens), §6.1 and §8.5 (demographics, 67.2% female), and §1 (indication and Limitation of Use).
- Dated capture of the brand’s own page — fda-rebyota-summary-basis-for-regulatory-action-163879 (opens in a new tab) captured FDA's 21-page Summary Basis for Regulatory Action. Source for Table 2, the drug-product specification — appearance, "Bacteroides Species Growth — Growth Observed", the viable bacterial count annotated (R), and a diversity criterion redacted as (b)(4) — for the footnote defining R as release and S as stability, for the 36-month stability programme and its eight testing timepoints, and for the statement that the product is not subject to CBER lot release. This document is the reason the CFU basis on this page reads at-manufacture rather than through-expiry.
How many of its strains have a human trial for what it is sold for
Across the frozen founding cohort, 0 of 294 organism slots (0.0%) carry an organism with a human randomised controlled trial for any male-specific outcome. Not for this product — for all 27 of the founding teardowns, taken together. That is the number to hold against any men’s probiotic, including this one.
Two further founding-cohort figures for context: only 43 of 294 organism slots carry a strain with any human RCT at all under the exact code printed on the label, and only 2 of 27 products have a published human trial of the finished formula — the thing actually in the bottle. All three figures divide by the frozen cohort of 27 teardowns and 294 organism slots, never by every teardown on this site.
For this product specifically, 0 organism slots carry a strain with a human RCT under the exact designator printed on the label.
A word on what a designator has to clear before it counts here. The organism must be named with the exact strain code that appears in the trial, the trial must be in humans, and the code must return that trial when a reader searches it. A species name does not qualify: the trials in this field are of strains, and a species contains thousands of them.
What it costs per day
What certification it holds, checked at the issuer’s own register
A badge on a bottle is a claim like any other. Every row below was checked — or not checked — at the certifier’s own public register, never at the badge. Across the frozen founding cohort, 2 of 27 products hold a certification we could confirm at the issuer — a founding-cohort figure, not a count over every teardown on this site.
| Programme | Status at the issuer | Checked |
|---|---|---|
| FDA Biologics License Application — BLA 125739, US license number 2112 | Confirmed at issuer | 31 July 2026 |
FDA Biologics License Application — BLA 125739, US license number 2112
Found on the certifier’s own public register.
Approved 30 November 2022 under §351(a) of the Public Health Service Act, verified directly in the approval letter PDF on FDA's own site alongside the 12-page package insert and the 21-page Summary Basis for Regulatory Action, all HTTP 200 and machine-readable. Identifiers - STN BL 125739/0, NDC 55566-9800-0 (single-dose carton) and 55566-9800-1 (shipper), HCPCS J1440. This is the only "certification" in this batch read at the issuing body's own record with no intermediary. Two scope caveats belong with it: the SBRA states "The product is not subject to CBER Lot Release testing. Accordingly, there is no requirement for submission of product samples to CBER", and package insert §13 states "No nonclinical toxicology studies were conducted."
How it differs from the same brand’s women’s version
Across the fourteen same-brand men’s-versus-women’s label diffs run inside the frozen founding cohort, zero men’s or default formulas contain a probiotic strain, identified by designator, that was selected on male-specific evidence. In eight of the fourteen the sex-specific differentiator is a botanical or a mineral, and in five of the fourteen the women’s SKU is better-specified, cheaper, or both — “better-specified” meaning the panel that discloses more, never the panel with more in it. The rule behind each of those counts, and all fourteen pairs classified against it , are published in full. Diffs run on teardowns added since sit outside this fourteen, and outside the sentence above.
This brand sells no women’s counterpart to this product, so there is no diff to run.
Every finding on this page, with the record behind it
Finding 1 the-potency-specification-is-a-five-hundred-fold-window
1×10⁸ to 5×10¹⁰ CFU/mL is 2.7 log₁₀ — a 500-fold range. Per 150 mL dose that is 1.5×10¹⁰ to 7.5×10¹² CFU. Two lots that both meet specification can differ by a factor of five hundred.
The record: REBYOTA package insert §11 DESCRIPTION and SBRA Table 2, REBYOTA DP Specification — open it (opens in a new tab)
Finding 2 the-labelled-cfu-range-is-a-release-specification-not-an-expiry-guarantee
SBRA Table 2 annotates the viable bacterial count (R), and the footnote defines R as "used for release". Potency is separately stability-tested at 0, 3, 6, 9, 12, 18, 24 and 36 months, but the number printed in the labelling is the release number.
The record: SBRA Table 2 and its footnote; stability commitment text, fda.gov/media/163879 — open it (opens in a new tab)
Finding 3 mechanism-of-action-not-established
Package insert §12.1, verbatim - "The mechanism of action of REBYOTA has not been established."
The record: REBYOTA package insert §12.1 (fda.gov/media/163587) — open it (opens in a new tab)
Finding 4 no-nonclinical-toxicology-studies-conducted
Package insert §13, verbatim - "No nonclinical toxicology studies were conducted."
The record: REBYOTA package insert §13 — open it (opens in a new tab)
Finding 5 the-six-month-durability-endpoint-failed
Package insert §14, verbatim - "The difference in sustained clinical response rate (9.1%; 95% CI: −3.6%, 21.7%) was not statistically significant between the REBYOTA (65.5%) and the placebo groups (56.5%)." The 8-week primary result held — 70.6% versus 57.5%, difference 13.1 points, 95% CrI 2.3–24.0, posterior probability of superiority 0.991 against a pre-defined threshold of 0.975, NNT about 7.6 — but the durability claim does not hold at 6 months.
The record: REBYOTA package insert §14; Bayesian analysis of NCT03244644 (PUNCH CD3, n=320) with NCT02299570 — open it (opens in a new tab)
Finding 6 placebo-success-was-fifty-seven-percent
Most people in the control arm did not recur either. The absolute gain is 13 points on top of a large spontaneous-resolution rate, and any consumer-facing summary that omits the placebo arm makes the product look several times more effective than the trial found it.
The record: REBYOTA package insert §14, model-estimated placebo success 57.5% (95% CrI 48.1–67.1) — open it (opens in a new tab)
Finding 7 made-from-human-faecal-matter-with-unrestricted-donor-diets
Package insert §5.1 warns the product "may carry a risk of transmitting infectious agents"; §5.3 warns it "may contain food allergens… The potential for REBYOTA to cause adverse reactions due to food allergens is unknown." Donors have no dietary restrictions.
The record: REBYOTA package insert §5.1 and §5.3 — open it (opens in a new tab)
Finding 8 no-cber-lot-release
SBRA, verbatim - "The product is not subject to CBER Lot Release testing. Accordingly, there is no requirement for submission of product samples to CBER."
The record: Summary Basis for Regulatory Action, fda.gov/media/163879 — open it (opens in a new tab)
Finding 9 the-fda-approved-product-is-being-commercially-wound-down
Ferring press release, 29 October 2025, verbatim - "we have decided to explore strategic options for Rebyota®… Ferring will reduce commercial efforts in the United States, while ensuring uninterrupted access for patients." The same release states "more than five thousand patients" treated to date.
The record: Ferring Pharmaceuticals press release, 29 October 2025 — open ithttps://www.ferring.com/ferring-pharmaceuticals-to-explore-strategic-options-for-rebyota/ — Address given, not linked: this site does not link out to the products it audits.
Finding 10 rectal-administration-in-office-or-via-home-health
A 150 mL rectal suspension with a 15-minute recumbent wait, given in-office or by home health. Not a capsule and never will be. Storage is an ultracold freezer at −60 °C to −90 °C, or 2–8 °C for up to 5 days including thaw, do not refreeze.
The record: REBYOTA package insert §2 and §16; SBRA 36-month shelf life at −80 °C — open it (opens in a new tab)
What we could not verify
Every gap below is published rather than deleted. Most are derived automatically from the empty fields in this page’s own record, so a gap cannot be hidden by leaving a box blank.
- A US retail price, and therefore the cost per day
- There is no retail price for a prescription biologic administered in a clinic, and the manufacturer's wholesale figure could not be reached — buyandbill gates WAC and ASP behind a login, so the widely repeated "$9,135 per unit effective 3 July 2024" is UNVERIFIED and is not published here as a number to rely on. Two verifiable anchors exist instead and are recorded rather than averaged. First, a peer-reviewed budget-impact analysis states verbatim "The price of FMBL was set at $9000" — and it is Ferring-funded, with a Ferring employee among the authors, Analysis Group co-authors paid by Ferring, and consulting fees to two further authors; the COI travels with the figure or the figure does not get cited. Second, the Medicare payment limit for Q3 2026 is $65.604 per HCPCS J1440 unit, and at 150 units per dose that is $9,840.60; the private-payer national median for January 2026 was $64.58 per unit, or $9,687 per dose. Cost per day is not a meaningful metric: one dose, one time. For scale, REBYOTA costs roughly as much as eighteen years of daily Life Extension FLORASSIST Mood Improve — and unlike the supplements it has an FDA-adjudicated efficacy finding.
- The manufacturer's wholesale acquisition cost
- The figure "$9,135 per unit effective 3 July 2024" appears in web-search summaries. No primary source could be reached — buyandbill gates WAC and ASP behind a login. Marked UNVERIFIED; two verifiable price anchors are used in its place and both carry their provenance.
- Parts of the chemistry, manufacturing and controls package
- The Summary Basis for Regulatory Action redacts the diversity assay method and several acceptance criteria as (b)(4) trade secret. The diversity criterion that forms part of the product's identity specification is therefore not readable.
- Any sex-stratified efficacy finding
- §8.5 addresses age and not sex, and no sex analysis is presented anywhere in the approved labelling. Nothing is asserted in either direction.
- The brand's account of REBYOTA's commercial position beyond the press release itself
- Ferring's 29 October 2025 release is quoted verbatim and is a primary source. Anything beyond its own words — market share, ongoing availability by region, what "reduce commercial efforts" means in practice — was not checked.
How to check every line of this page yourself
Nothing on this page requires trusting us. Every claim above resolves to a record you can open:
- Open the NIH Dietary Supplement Label Database record linked at the top of this page. It is the label the manufacturer filed, not our transcription of it.
- Compare the CFU line and the suggested-use line against the disclosure table above. If they disagree with us, we are wrong and we want to know.
- Take any strain designator from the panel and run the query printed beside it. The query is published precisely so you can get a different answer than we did.
- Divide the price by the number of days the label’s own dose instructions make the container last. That arithmetic is the whole of the cost-per-day row.
- Search the certifier’s own register for this product, not for the brand. A company can participate in a programme without this product being on its list.
REBYOTA is on this site to break the scoring method, and it does it in one line.
It names no strains. Its identity specification, in FDA’s own Summary Basis for Regulatory Action, is “Bacteroides Species Growth — Growth Observed”, a viable bacterial count, and a diversity criterion redacted as trade secret. There is no ATCC, no DSM, no CNCM, no NCIMB anywhere in the approved labelling. The product is a donor-stool consortium; a strain list is not merely absent, it is conceptually inapplicable.
And it is still among the best-documented products in this project. A 12-page package insert, a 21-page regulatory review and an approval letter, all free, all machine-readable, all published by the agency that reviewed them. A licence — BLA 125739, US license 2112, approved 30 November 2022 — read directly at the issuer with no intermediary. A pre-specified Bayesian efficacy analysis. A 36-month stability programme testing potency at eight defined timepoints.
So: disclosure of strain names and evidentiary strength are orthogonal. Any ranking that counts named strains puts this product below a supermarket gummy.
Now the things a reader is owed, because a licence is not a blank cheque.
The potency window is 500-fold. 1×10⁸ to 5×10¹⁰ CFU/mL — 2.7 log₁₀. Two lots that both pass specification can differ by a factor of five hundred.
The number on the label is a release specification. The SBRA’s own footnote — “R=used for release, S=used for stability” — settles it. Potency through the dating period is monitored separately and enforced, which makes this materially stronger than any supplement’s at-manufacture footnote. It is still not an at-expiry guarantee, and it should not be described as one.
The 6-month durability endpoint failed. Verbatim from the approved label: the difference in sustained clinical response “was not statistically significant” — 65.5% versus 56.5%, 95% CI −3.6% to 21.7%. The 8-week result held: 70.6% versus 57.5%, a 13.1-point difference, posterior probability of superiority 0.991 against a pre-set 0.975, number needed to treat about 7.6. Note the placebo arm. 57.5% of the control group did not recur either.
The mechanism has not been established, no nonclinical toxicology studies were conducted, the product is not subject to CBER lot release, and it is made from human faecal matter from donors with no dietary restrictions — all of it stated on the approved label, by the sponsor.
Two last things. The instructive contrast for anyone reading supplement copy: REBYOTA is allowed to say “indicated for the prevention of recurrence of Clostridioides difficile infection” — a disease claim — because a BLA was filed, reviewed and approved. The same sentence a supplement cannot lawfully say costs about $9,000 and eleven years of clinical development to be allowed to say. And the product was studied in a population that was 67.2% female, with no men’s version, no women’s version, and no sex-stratified claim anywhere.