Biote, read out of its own filings rather than its own brochure

What is Biote?

Biote is a training and certification business for practitioners who offer hormone pellet therapy. Its Q2 2026 Form 10-Q defines it in a sentence: “Biote trains physicians and nurse practitioners in hormone optimization using bioidentical hormone replacement pellet therapy in men and women experiencing hormonal imbalance.” A physician or nurse practitioner completes the Biote Method certification, and that practitioner then prescribes compounded pellets and performs the insertion in their own clinic. Biote sells the training, the software, the pellets and the marketing support to the clinic. It does not see patients, does not write prescriptions and does not set what you pay.

That distinction is the one most coverage of the brand collapses, and it changes the questions worth asking. There is no single “Biote price” because the practitioner sets it. There is no Biote clinical trial because Biote is not the drug sponsor. The things you can hold the company to are the ones it files: the annual report, the quarterly report and the FDA enforcement record attached to the subsidiary that makes the pellets.

How does Biote make money?

From clinics, not from patients, and the filing says so without hedging.

Alongside the pellets sits a supplement line. The FY2025 annual report puts it at 26 branded dietary supplements priced between $10.00 and $126.50, approximately 22% of 2025 revenue, sold through the same certified practitioners. Scale, from the same filing: over 9,200 Biote-certified practitioners in more than 5,300 partnered clinics, with approximately 850 new partnered clinics in 2025, and 10 core states generated approximately 53% of revenue.

Is Biote FDA approved?

No, and you do not have to take our word for it. Here is the company telling its own investors, in the section of the annual report where understating a risk carries securities liability.

"Compounded drugs are not approved by the FDA. As part of the Biote Method, a practitioner may prescribe a compounded bioidentical hormone. These pellets, currently compounded by 503B outsourcing facilities, are not subject to the FDA new drug approval process."

The mechanism is statutory rather than discretionary. 21 U.S.C. 353b, Outsourcing facilities names three sections of the same title, one of them section 355, the requirement to hold an approved new drug application, and says they "shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met". The sections switched off include section 355, which is the requirement to hold an approved new drug application. That is the legal mechanism by which a compounded pellet reaches a patient without FDA approval of the drug.

For the estradiol pellet the position is simpler than any argument about pathways. A dosage-form pass across every estradiol product in Drugs@FDA returns 0 pellet entries and 0 implant entries. The only marketed FDA-approved hormone pellet of any kind is TESTOPEL, ANDA 080911, approved in 1972 through the generic pathway and labelled males only. Full workings on our hormone pellets page.

Is a pellet recall unusual?

No, and publishing the Biote recall without this table would be unfair. We pulled every record in the openFDA drug enforcement database whose product description contains the word pellet, 170 records, and grouped them by FDA event. Below are the 16 events that include at least one testosterone, estradiol, estrogen or progesterone pellet product. We have not seen this published anywhere, which is the only reason we built it.

Record counts and quantity totals are ours, summed from the records inside each event. Read the unit rather than the number: the enforcement records do not use one. Some print pellets, some print the vials the pellets shipped in, and the two oldest events print bare units, so these totals cannot be added across rows and we do not add them. Where an event has records that printed no quantity at all, the cell says how many did print one. Where no record in the event printed one, the cell says so rather than showing a zero. Rerun the query. One limit worth stating: this is a complete pass over that endpoint on that query on 2026-08-16, not a complete history of every pellet recall ever. A record that never used the word pellet in its product description would not be caught.

Is Biote safe?

Separate the company from the route, because the evidence about each is different and mixing them produces a worse answer than either.

On the company there are two records, and the recall is the recent one: a voluntary Class II recall of its subsidiary's pellets for potential metal particulate matter, disclosed by the company itself and conducted with the FDA's knowledge, with no published finding of patient injury attached to it. We looked for one and did not find one, so we publish none.

The older record is the one nobody links from a brand page, and it names the company. In a statement dated 2019-09-09 the U.S. Food and Drug Administration wrote: "During an inspection in 2018 of BioTE Medical, our investigators uncovered information about 4,202 adverse events that had never been reported to the agency. The adverse event information our investigators found suggested compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion. However, because the reports lacked certain critical information, the FDA was able to attribute only a small percentage of the adverse events (61 reports), such as pellet extrusion and cellulitis, to the use of compounded hormone pellets containing testosterone. The company that collected the adverse events did not send them to us during the five years they occurred between 2013 and 2018." Both numbers belong in the same sentence and usually are not. The agency found 4,202 adverse events that had not been reported to it, and it was able to attribute 61 of them to compounded testosterone pellets. The company named is BioTE Medical, the operating business whose SEC filings the rest of this page quotes. Read the statement, via the Internet Archive because fda.gov returns a 404 to automated clients.

On the route, four bodies have examined compounded hormone pellets and none endorses them. ACOG is the most specific, in Clinical Consensus No. 6, Compounded Bioidentical Menopausal Hormone Therapy: "Based on the lack of safety data and inability to remove the pellet, ACOG recommends preparations other than pellet therapy for the delivery of testosterone." Its stated mechanism is the one that separates this route from every other: "unlike other preparations that can be easily discontinued (eg, topical creams and pills), the pellet is not designed to be removed, but instead to dissolve over time. Generally, new pellets are inserted every 3 to 6 months. This route of administration potentially exposes the user to testosterone over a longer period of time compared with oral or topical products."

The most citable comparative evidence is Menopause 2021;28(8):867-874, a retrospective cohort of 539 postmenopausal women, 384 on pellets and 155 on FDA-approved therapy. It found any side effect in 57.6% (221/384) of the pellet group against 14.8% (23/155) of the FDA-approved group, P<0.00001. Retrospective and observational. It measures association in records already collected, so it cannot establish that the pellet caused the difference, and the two groups were not randomly assigned.

What are the alternatives to Biote?

FDA-approved estradiol exists as a patch, gel, spray, pill, cream and vaginal preparation. Every one of them is batch-tested to an approved specification, and every one of them stops when you stop it, which is the property ACOGsays the pellet does not have. Below is every platform on our roster that dispenses an FDA-approved formulary, score-sorted, compounded-only formularies excluded. The price column reads each provider's own disclosure, so a per-visit fee is labelled as one and never rewritten into a monthly number.

The cheapest all-in monthly price on an FDA-approved formulary across this roster is Alloy at $40/mo, medication included, which annualises to $480. Hold that against the roughly $350 to $410 per insertion at the two clinics that publish a women's figure, three to four times a year the three clinics above publish, before labs, and decide what the procedure is buying you. The multiplication by twelve is ours; the monthly price comes from our own verified roster.

The molecules themselves, priced provider by provider: estradiol and progesterone, which is the second drug anyone with a uterus needs alongside systemic estrogen. Scores and methodology on our rankings, and the FDA-approved against compounded distinction in full on the bioidentical HRT guide.

Sources

• biote Corp, Form 10-Q for the quarterly period ended 2026-06-30, filed 2026-08-07, SEC EDGAR Source for the business model, the revenue recognition policy, the recall cost and revenue estimates, the operating lines and the legal posture.
• biote Corp, Form 8-K filed 2026-01-26, Item 8.01 Other Matters, SEC EDGAR Source for the recall announcement and the January estimates.
• biote Corp, Form 10-K for the fiscal year ended 2025-12-31, SEC EDGAR (CIK 0001819253) Source for the risk disclosure, the practitioner and clinic counts and the supplement share of revenue.
• SEC XBRL companyfacts API, CIK 0001819253 Source for every revenue and net income figure in the period table.
• FDA drug enforcement records, F.H. INVESTMENTS, Inc. (dba Asteria Health), event 98344 (openFDA)
• FDA drug enforcement records, all products with pellet in the product description (openFDA)
• 21 CFR 7.3(m), recall classification definitions, eCFR
• 21 U.S.C. 353b, Outsourcing facilities, US Code on govinfo
• U.S. Food and Drug Administration, Statement on improving adverse event reporting of compounded drugs to protect patients, 2019-09-09 Source for the 2018 inspection finding. Linked through the Internet Archive because fda.gov returns a 404 to automated clients.
• ACOG, Clinical Consensus No. 6, Compounded Bioidentical Menopausal Hormone Therapy. Obstet Gynecol 2023;142(5):1266-1273. Replaces Committee Opinion No. 532 (2012). Endorsed by ASRM.
• Jiang X, Bossert A, Parthasarathy KN, Leaman K, Minassian SS, Schnatz PF, Woodland MB. Safety assessment of compounded non-FDA-approved hormonal therapy versus FDA-approved hormonal therapy in treating postmenopausal women. Menopause 2021;28(8):867-874 (PMID 33973545)
• Drugs@FDA, all estradiol products by dosage form (openFDA)
• TESTOPEL prescribing information, label effective 2025-07-17 (openFDA)
• Robinson Wellness, published Biote pricing (clinic-published, unaudited)
• Berman Women's Wellness, published Biote pricing (clinic-published, unaudited)
• Lush RX Med Spa, published Biote pricing (clinic-published, unaudited)

This is general information, not medical advice, and not investment advice. Hormone pellets are prescribed and implanted by a licensed clinician, and whether any hormone therapy fits your history is a decision for you and that clinician. Every primary source on this page was read and verified on 2026-08-16, and every claim about biote Corp is either quoted from a filing it made itself or taken from an FDA enforcement record whose number is printed above. Written and reviewed by Iacob Pastina. If anything here is wrong, including anyone at Biote reading it, our corrections policy says how we fix it and how fast.