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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

Y-O Management LLC, dba Natural Remedy Store: Active Male 500mg Supplement Recalled for Undeclared Tadalafil

Agency Publication Date: March 27, 2020
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Summary

Y-O Management LLC, doing business as Natural Remedy Store, is recalling approximately 19,156 packets of Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement. FDA laboratory testing discovered that the product contains Tadalafil, an undeclared ingredient that is an FDA-approved drug used to treat erectile dysfunction. Because this ingredient was not listed on the label, the product is considered an unapproved drug. The recalled supplements were distributed in Georgia and Texas. Consumers should stop using the product immediately and seek medical advice if they have health concerns.

Risk

Tadalafil can interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. This poses a significant health risk to consumers with diabetes, high blood pressure, high cholesterol, or heart disease who are often prescribed nitrates.

What You Should Do

  1. Check your supply for packets labeled 'Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement.' All lot numbers that are currently within their expiration date are affected by this recall.
  2. Stop using this product immediately due to the risk of dangerous drug interactions.
  3. Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product, particularly if you take medications containing nitrates.
  4. Contact your pharmacist for guidance regarding the undeclared ingredient and return any unused packets to the place of purchase for a full refund.
  5. Contact Natural Remedy Store at 1-877-543-3501 for further instructions or to ask questions about the recall.
  6. For additional questions or to report a safety concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund upon return of product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement
Lot Numbers:
All lots remaining within expiry.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85232
Status: Resolved
Manufacturer: Y-O Management LLC, dba Natural Remedy Store
Sold By: Natural Remedy Store; Natural Remedies
Manufactured In: United States
Units Affected: 19156 packets estimated distributed
Distributed To: Georgia, Texas
Agency Last Updated: April 4, 2020

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.