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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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Critical RiskFDA Drug
Medications & Supplements/Dietary Supplements

Vitality Male Enhancement Capsules Recalled for Undeclared Drug Ingredients

Agency Publication Date: March 17, 2025
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Summary

One Source Nutrition, Inc, is recalling all lots of its Vitality Fast Acting Male Enhancement Product (Xtreme Potency), a dietary supplement sold in individual packets and six-capsule bottles. The recall affects 300 individually wrapped capsules and 20 bottles because the product contains undeclared sildenafil and tadalafil, which are the active ingredients in prescription medications for erectile dysfunction. Consumers should not use this product as these undeclared ingredients can interact dangerously with other medications.

Risk

The undeclared drug ingredients sildenafil and tadalafil can interact with nitrates found in some prescription drugs, such as nitroglycerin, and may cause blood pressure to drop to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease frequently take nitrates and are at significant risk of harm.

What You Should Do

  1. This recall affects all lots of Vitality Fast Acting Male Enhancement Product (Xtreme Potency) sold as individual capsules per packet and six-capsule bottles.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact One Source Nutrition, Inc, directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Vitality Fast Acting Male Enhancement Product (Xtreme Potency)
Variants: One Capsule per Packet, 6 capsules per bottle, Xtreme Potency
Lot Numbers:
All lots

Marketed as a dietary supplement; found to be tainted with undeclared drug ingredients.

Product Images

Image 1: Label for 250 mL Excel Bag containing PHENYLephrine 40 mg added to 0.9% Sodium Chloride

Image 1: Label for 250 mL Excel Bag containing PHENYLephrine 40 mg added to 0.9% Sodium Chloride

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96328
Status: Active
Manufacturer: One Source Nutrition, Inc,
Manufactured In: United States
Units Affected: a) 300 individually wrapped capsules b) 20 bottles
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 FDA Press Release 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.