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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: May 9, 2025
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Summary

Empower Clinic Services, LLC (dba Empower Pharmacy) is recalling 8,230 vials of Testosterone Cypionate Injection (200 mg/mL, 5 mL Sterile Multiple-Dose Vial). This voluntary recall was initiated because the pharmacy cannot assure the sterility of the product. Using a medication that is not sterile can lead to serious and potentially life-threatening infections at the injection site or throughout the body.

Risk

Injecting a product that lacks sterility assurance can introduce bacteria or other contaminants directly into the body, posing a moderate risk of infection. No injuries or adverse events have been reported to date, but the risk of infection remains for any patient who uses the affected medication.

What You Should Do

  1. This recall affects 5 mL sterile multiple-dose vials of Testosterone Cypionate Injection (200 mg/mL) compounded by Empower Pharmacy with a compounding date of 08/20/2024.
  2. Check the label on your vial for Lot number 202364 and a Beyond Use Date (expiration) of 05/28/2025.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Empower Pharmacy at 877-562-8577 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Testosterone Cypionate Injection (5 mL)
Variants: 200 mg/mL, CIII, Rx Only, Sterile Multiple-Dose Vial
Lot Numbers:
202364 (Exp 5/28/2025)
Date Ranges: Compounding Date: 08/20/2024

Compounded by Empower Pharmacy, Houston, TX.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96808
Status: Active
Manufacturer: Empower Clinic Services, LLC dba Empower Pharmacy
Sold By: Empower Pharmacy
Manufactured In: United States
Units Affected: 8,230 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.