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Is Asteria Health legit?

Asteria Health is a real FDA-registered 503B outsourcing facility in Birmingham, Alabama, owned by Biote, and in January 2026 it started a Class II recall of testosterone and estradiol pellets for possible metal particles [1] [2].

Updated By the Wellchosen Health editorial team

FDA issued it a 10-item Form 483 after a December 2025 inspection [3]. Biote says Asteria makes most of the hormone pellets practitioners in its network use [4].

Asteria Health is a 503B outsourcing facility in Birmingham, Alabama that compounds hormone pellets for Biote.

FDA actions
Form 483 Dec 19, 2025; Class II pellet recall Jan 26, 2026 [3] [2]
Reviewed providers using it
Biote (owner) [4]
Checked
Oct 24, 2026

See all pharmacies we checked

What Asteria Health is

Biote acquired Asteria Health, "a privately held 503B outsourcing facility to compound bioidentical hormones," on Mar 18, 2024 [4]. FDA lists it under its legal name, F.H. Investments, Inc., at 432 Industrial Ln, Birmingham, AL [1] [3]. Biote's 10-K says a majority of the hormone pellets used by practitioners in Biote's network are made there [4].

503B registration

On FDA's registered outsourcing facility list, checked Oct 24, 2026, F.H. Investments shows a most recent registration of Dec 2, 2025, a last inspection of Dec 19, 2025, a Form 483 issued, and intent to compound sterile drugs from bulk ingredients [1]. Registration means FDA received the required information. It does not mean FDA approved the facility or its drugs [5]. Outsourcing facilities must follow current good manufacturing practice and FDA inspects them on a risk-based schedule [6].

FDA record

FDA actions on record for Asteria Health (F.H. Investments, Inc.), checked Oct 24, 2026
DateActionDetails
Sep 10, 2021FMD-145 letterListed on FDA's compounding actions page [7]
Nov 8, 2024Form 483Listed on FDA's compounding actions page [7]
May 8, 2025FMD-145 letterListed on FDA's compounding actions page [7]
Dec 5 to 19, 2025Inspection, Form 483 with 10 observationsIncluded no process validation, sterility claims without sterilization validation, contamination and potency failures not properly investigated, and a 365-day expiration based on another facility's data [3]
Jan 26, 2026Recall, Class II, 25 entriesTestosterone and estradiol pellets, "potential presence of metal particulate matter," distributed nationwide; status ongoing on Oct 24, 2026 [2]
FMD-145 letters are FDA's letters closing out an inspection with its view of the firm's response. A Form 483 is a list of inspector observations, not a final finding.

We did not find an FDA warning letter to Asteria Health [7].

Which providers we review use Asteria

Biote's own filing names Asteria as its compounder for most pellets used by practitioners in Biote's network [4]. Read our Biote review and the hormone therapy guide. Pellets are covered on our pellet cost page. Hims & Hers is another company we review that owns a 503B facility: MedisourceRx.

If you have Biote pellets

Any drug Asteria Health compounds is not FDA-approved. FDA says it does not check the safety, effectiveness or quality of compounded drugs before they are sold [6]. That holds for compounded semaglutide and compounded tirzepatide too.

  1. Read the label. The pharmacy name and address on the vial or box should match a pharmacy you can look up. FDA lists a pharmacy name on the label that you think might be fraudulent as a red flag [8].
  2. Check the license with the state board. For a 503B facility, start with FDA's registered outsourcing facility list [1], then check the state board. FDA's BeSafeRx page links every state board of pharmacy license search [9]. Check your own state too.
  3. Check the website with NABP. The National Association of Boards of Pharmacy runs a Safe Site Search on Safe.Pharmacy and says a safe online pharmacy accepts only valid prescriptions, is licensed where it is located and where you live, and has a pharmacist you can reach [10].
  4. Never buy research-use-only vials. They are not legal for human use and are not pharmacy products.
  5. Report problems. FDA asks people to report side effects or quality problems with any medicine to MedWatch [8]. For a medical emergency, call 911.

Ask the practice that placed your pellets whether your lot was part of the January 2026 recall [2]. For testosterone treatment options, see testosterone therapy. Other pharmacies are on all the pharmacies we checked.

Questions people ask

Is Asteria Health legit?

Asteria Health is an FDA-registered 503B outsourcing facility in Birmingham, Alabama, listed as F.H. Investments, Inc. and owned by Biote [1] [4]. FDA issued it a 10-item Form 483 on Dec 19, 2025 [3].

Did Asteria Health recall pellets?

Yes. FDA recall records show a Class II recall started Jan 26, 2026 for testosterone and estradiol pellets over "potential presence of metal particulate matter," with 25 entries and status ongoing as of Oct 24, 2026 [2].

Who owns Asteria Health?

Biote. Its 10-K says it acquired Asteria Health, a 503B outsourcing facility, on Mar 18, 2024 [4].

Are Biote pellets FDA-approved?

No. Pellets made at an outsourcing facility are compounded drugs, and FDA says compounded drugs are not FDA-approved [6]. Outsourcing facilities do not need FDA approval of their products [5].

Has Asteria Health had an FDA warning letter?

We found none. FDA's compounding actions page lists Form 483s in Nov 2024 and Dec 2025 and FMD-145 letters in Sep 2021 and May 2025, checked Oct 24, 2026 [7].

Medical review: pending. A licensed clinician has not yet reviewed this page.

Sources

10 cited
  1. Registered outsourcing facilities. FDA, 2026-10-22 (accessed 2026-10-24).
  2. openFDA drug enforcement (recall) records: recalling firm F.H. Investments, Inc. dba Asteria Health. FDA (openFDA), Oct 24, 2026.
  3. Form FDA 483, F.H. Investments, Inc. dba Asteria Health, Birmingham, AL. FDA, Dec 19, 2025.
  4. biote Corp. Form 10-K for fiscal year 2025. biote Corp. (SEC filing), Mar 2026.
  5. Questions and answers: outsourcing facility registration. FDA, 2019-07-02 (accessed 2026-10-24).
  6. Compounding and the FDA: questions and answers. FDA, 2025-09-16 (accessed 2026-10-24).
  7. Compounding: inspections, recalls, and other actions. FDA, 2026-10-22 (accessed 2026-10-24).
  8. FDA's concerns with unapproved GLP-1 drugs used for weight loss. FDA, 2026-10-01 (accessed 2026-10-24).
  9. Locate a state-licensed online pharmacy. FDA BeSafeRx, 2024-11-13 (accessed 2026-10-24).
  10. Find safe online pharmacies. National Association of Boards of Pharmacy (Safe.Pharmacy), 2026-07-01 (accessed 2026-10-24).

This page is general information, not medical advice. Talk with a licensed clinician about your own care.

See all pharmacies we checked