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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Qualgen Testosterone 200 mg Pellets Recalled for Labeling Error

Agency Publication Date: July 14, 2025
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Summary

Qualgen, LLC is recalling 2,832 amber vials of Testosterone 200 mg Pellets, a compounded medication used for hormone replacement. The recall was initiated because of a printing issue that resulted in some vials having incorrect or missing lot numbers and expiration dates on their labels. If you are using this medication, please check your vials to see if the labeling information is correct.

Risk

The risk to health is low; however, incorrect or missing lot numbers and expiration dates can make it difficult for patients and healthcare providers to ensure the medication is not expired or part of a specific production batch.

What You Should Do

  1. This recall affects Qualgen Testosterone 200 mg Pellets (compounded product) packaged in 1mL amber vials with NDC 69761-202-01.
  2. Identify your medication by looking for lot number 1043 with an expiration date of 2/10/2026 printed on the vial label.
  3. If you have health concerns about using this product, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Qualgen, LLC directly for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or want to report an issue.

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 200 mg Pellet (1mL)
Variants: 200 mg strength, Compounded product, 1mL amber vial
Lot Numbers:
1043 (Exp. 2/10/2026)
NDC:
69761-202-01

Recall #: D-0517-2025; Qualgen 14844 Bristol Park Blvd Edmond OK 73013

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97086
Status: Active
Manufacturer: Qualgen, LLC
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 2,832 amber 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.