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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

New Vitalis Pharmacy Testosterone Recalled for Sterility Concerns

Agency Publication Date: September 30, 2021
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Summary

New Vitalis Pharmacy has voluntarily recalled 1,347 vials of Testosterone Cypionate and Testosterone Propionate (180mg/mL, 20mg/mL) due to concerns that the products may not be sterile. The recall affects 1 mL vials used for injection. Using a medication that is not properly sterilized can lead to serious, potentially life-threatening infections at the injection site or in the bloodstream. While no injuries or illnesses have been reported to date, the pharmacy is recalling specific lots distributed across the United States to protect patient safety.

Risk

The lack of assurance of sterility means the injectable medication could contain bacteria or other contaminants. Injecting a non-sterile product can cause severe infections, including sepsis, which requires immediate medical attention.

What You Should Do

  1. This recall affects 1 mL vials of Testosterone Cypionate and Testosterone Propionate (180mg/mL, 20mg/mL) distributed nationwide by New Vitalis Pharmacy.
  2. Check your medication label for the manufacturer name 'New Vitalis Pharmacy' and any of the following lot numbers: AL07202021, AL07272021, AL08032021, AL08102021, AL08172021, or AL08242021.
  3. If you have health concerns or believe you have experienced a reaction from this medication, 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 New Vitalis Pharmacy for further instructions regarding the return of affected vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.

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 Testosterone Propionate (1 mL vial)by New Vitalis Pharmacy
Variants: 180mg/mL, 20mg/mL, Rx Only
Lot Numbers:
AL07202021 (Exp 9/18/21)
AL07272021 (Exp 9/25/21)
AL08032021 (Exp 10/2/21)
AL08102021 (Exp 10/9/21)
AL08172021 (Exp 10/16/21)
AL08242021 (Exp 10/23/21)

Manufacturer: New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213. Total quantity: 1,347 vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88733
Status: Resolved
Manufacturer: New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Sold By: New Vitalis Pharmacy
Manufactured In: United States
Units Affected: 1,347 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.