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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

Happy Together, Inc.: 5K Premium Enhancement Capsules Recalled for Undeclared Drug Ingredients

Agency Publication Date: January 22, 2019
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Summary

Happy Together, Inc. is recalling all 5K Premium Enhancement male enhancement capsules because FDA laboratory analysis found them to contain sildenafil and tadalafil, which are undeclared drug ingredients. These products are being marketed without FDA approval and were sold online in 1-count blister cards contained within boxes of 30. Consumers should immediately stop using these products and contact their healthcare provider for guidance, as the undeclared ingredients can interact dangerously with other medications.

Risk

The undeclared sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), potentially lowering blood pressure to dangerous or life-threatening levels. This pose a significant risk to individuals with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.

What You Should Do

  1. Identify if you have the affected product by checking for '5K Premium Enhancement' capsules (5000 mg) sold in 1-count blister cards within a box of 30.
  2. Check the packaging for UPC 649964965644 and verify if the lot is within its expiration date, as all currently unexpired lots are included in this recall.
  3. Stop using the product immediately and contact your doctor or healthcare provider if you have experienced any health problems that may be related to taking this product.
  4. Return any unused product to the place of purchase for a full refund and contact Happy Together, Inc. for further instructions regarding disposal or return.
  5. Contact your pharmacist for guidance on how to handle the potentially tainted supplement and for assistance with identifying similar products to avoid.
  6. For additional questions or to report a reaction, 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

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

How to: Consumers are advised to contact their healthcare professional and return the product to the place of purchase.

Affected Products

Product: 5K Premium Enhancement capsule (5000 mg)
UPC Codes:
649964965644
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81913
Status: Resolved
Manufacturer: Happy Together, Inc.
Sold By: Internet
Manufactured In: United States
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.