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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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High RiskFDA Drug
Medications & Supplements/Dietary Supplements

Antoto-K: Thumbs Up 7 Red 70K Recalled for Undeclared Sildenafil and Tadalafil

Agency Publication Date: May 4, 2021
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Summary

Antoto-K is recalling approximately 200 cartons of Thumbs Up 7 Red 70K, a dietary supplement marketed for male enhancement. FDA analysis discovered that these 10-count blister pack cartons contain sildenafil and tadalafil, which are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These ingredients are not listed on the product label and make the product an unapproved drug. Consumers should contact their healthcare provider or pharmacist for guidance regarding this product.

Risk

The presence of undeclared sildenafil and tadalafil poses a serious health risk because these ingredients can interact with nitrates found in some prescription drugs (such as nitroglycerin), potentially lowering blood pressure to dangerous or life-threatening levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and are at higher risk of adverse effects.

What You Should Do

  1. Check your product packaging for Thumbs Up 7 Red 70K in 10-count blister pack cartons with UPC 6 17135 89467 3.
  2. Verify if your product is affected by checking the lot information; all lots that are currently within their expiration date are included in this recall.
  3. Immediately stop using the product and return any unused portions to the place of purchase for a refund.
  4. Contact your healthcare provider or pharmacist if you have used this product and have concerns about your health or potential drug interactions.
  5. Contact the manufacturer, Antoto-K, for further instructions regarding the return and refund process.
  6. For additional questions, 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

Return unused product for a refund

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

Affected Products

Product: Thumbs Up 7 Red 70K (10 count blister pack cartons)
UPC Codes:
617135894673
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87627
Status: Resolved
Manufacturer: Antoto-K
Sold By: Ummzy LLC
Manufactured In: United States
Units Affected: 200 cartons
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.