Hormone pellet recall at biote Corp (NASDAQ: BTMD) brings charges

Rhea-AI Filing Summary

biote Corp. reported that its wholly owned subsidiary, F.H. Investments, Inc. (Asteria Health), has initiated a voluntary recall of certain hormone pellet lots shipped between May 20, 2025 and January 19, 2026 because of a potential presence of metal particulate matter. The recall is being carried out with the knowledge of the U.S. Food and Drug Administration.

The company expects to record a one-time charge of approximately $1.3 million to fourth quarter cost of products for the write-off of affected pellet inventory and currently estimates additional recall-related costs of about $1.0 million in 2026. biote does not believe its fourth quarter business was affected beyond the inventory write-off and does not anticipate a material impact on its ability to supply pellets to practitioner partners or on practitioners’ ability to serve patients.

Insights

Healthcare equity analyst

Voluntary recall brings one-time charges but limited supply impact per company.

biote Corp. disclosed that subsidiary Asteria Health has begun a voluntary recall of specified hormone pellet lots over potential metal particulate presence, with the U.S. Food and Drug Administration informed. This introduces operational and reputational considerations around quality control in compounded hormone products.

Financially, management expects a one-time $1.3M charge in fourth quarter cost of products for inventory write-offs and about $1.0M of additional recall costs in 2026. The company states it does not see broader fourth quarter business impact beyond the write-off and does not anticipate a material effect on pellet availability for practitioners or patient service, so near-term revenue disruption is described as limited based on this disclosure.

The scale of the recall and any further financial or regulatory consequences will be clearer when biote provides more detail with its fourth quarter results. Future disclosures will show whether quality-related investments or changes in manufacturing and oversight at Asteria Health meaningfully alter cost structure or growth plans.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 26, 2026

biote Corp.

(Exact name of registrant as specified in its charter)

Delaware		001-40128		85-1791125
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

1875 W. Walnut Hill Ln #100

Irving, Texas 75038

(Address of principal executive offices, including zip code)

(844) 604-1246

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbols		Name of each exchange on which registered
Class A common stock, par value $0.0001 per share		BTMD		The Nasdaq Stock Market LLC

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencements communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Matters.

On January 26, 2026, F.H. Investments, Inc. (“Asteria Health”), a 503B manufacturer of compounded bioidentical hormones and wholly-owned subsidiary of biote Corp. (the “Company”), out of an abundance of caution initiated a voluntary recall of specific lots of hormone pellets shipped by Asteria Health between May 20, 2025 and January 19, 2026 due to the potential presence of metal particulate matter. The Company has notified affected practitioners of the voluntary recall. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (the “FDA”).

While it is too early to ascertain the total cost of the voluntary recall, the Company expects to record a one-time charge of approximately $1.3M to its fourth quarter cost of products related to write-off of impacted Company pellet inventory. The Company will likely incur some additional costs related to the recall in 2026 which are currently estimated to be approximately $1.0M. The Company does not believe that its fourth quarter business was impacted by the recall beyond the impact of the inventory write-off. The Company does not anticipate the recall will materially impact its ability to provide pellets to its practitioner partners or the ability of practitioners to service patients. More details on the potential financial impact of this event will be provided when the Company reports its fourth quarter results.

Forward-Looking Statements

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Some of the forward-looking statements can be identified by the use of forward-looking words. Statements that are not historical in nature, including the words “may,” “can,” “should,” “will,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “hope,” “believe,” “seek,” “target,” “continue,” “could,” “might,” “ongoing,” “potential,” “predict,” “would” and other similar expressions, are intended to identify forward-looking statements, and includes statements and information concerning the voluntary recall and any impact of the recall on the Company’s business or financial results. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements, including but not limited to: anticipated benefits and successful execution of our organizational restructuring; the success of our dietary supplements to attain significant market acceptance among clinics, practitioners and their patients; our customers’ reliance on certain third parties to support the manufacturing of bio-identical hormones for prescribers; our and our customers’ sensitivity to regulatory, economic, environmental and competitive conditions in certain geographic regions; our ability to increase the use by practitioners and clinics of the Biote Method at the rate that we anticipate or at all; our ability to grow our business; the significant competition we face in our industry; the impact of strategic acquisitions and the implementation of our growth strategies; our limited operating history; our ability to protect our intellectual property; the heavy regulatory oversight in our industry; changes in applicable laws or regulations; changes to international tariffs, U.S. trade policy or similar government actions; geopolitical tensions; the inability to profitably expand in existing markets and into new markets; the possibility that we may be adversely impacted by other economic, business and/or competitive factors, including the impact of hurricane and other natural disasters; and future exchange and interest rates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and other risks and uncertainties described in the “Risk Factors” section of Biote’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2025, as supplemented by Biote’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, and other documents filed by Biote from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Biote assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Biote does not give any assurance that it will achieve its expectations.

SIGNATURE

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

biote Corp.
By:		/s/ Bret Christensen
Name:		Bret Christensen
Title:		Chief Executive Officer

Date: January 26, 2026

FAQ

What event did biote Corp. (BTMD) disclose in this 8-K?

biote Corp. reported that its wholly owned subsidiary F.H. Investments, Inc. (Asteria Health) initiated a voluntary recall of certain hormone pellet lots due to the potential presence of metal particulate matter.

Which products are affected by biote Corp.’s hormone pellet recall?

The voluntary recall covers specific lots of hormone pellets manufactured by Asteria Health and shipped between May 20, 2025 and January 19, 2026.

How much does biote Corp. expect the recall to cost?

biote expects a one-time charge of approximately $1.3 million in its fourth quarter cost of products for inventory write-offs and currently estimates about $1.0 million of additional recall-related costs in 2026.

Will the biote Corp. recall affect product supply to practitioners?

The company does not anticipate that the voluntary recall will materially impact its ability to provide pellets to practitioner partners or practitioners’ ability to service patients.

Is the FDA involved in biote Corp.’s hormone pellet recall?

Yes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration, according to biote Corp.

Does biote Corp. expect broader fourth quarter business impact from the recall?

biote states that it does not believe its fourth quarter business was impacted by the recall beyond the effect of the approximately $1.3 million inventory write-off.

When will biote Corp. provide more financial detail on the recall’s impact?

The company indicated that more details on the potential financial impact of the voluntary recall will be provided when it reports its fourth quarter results.