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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

Gadget Island, Inc: Various Male Enhancement Capsules Recalled for Undeclared Drug Ingredients

Agency Publication Date: December 4, 2017
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Summary

Gadget Island, Inc. is recalling approximately 1,485 units of various male enhancement capsules, including RHINO 7 Platinum 5000, PapaZen 3300, FIFTY SHADES 6000, and grande X 5800. These products, sold in 1-capsule packets, were found to contain undeclared active pharmaceutical ingredients including sildenafil, desmethyl carbodenafil, and tadalafil. These are the active ingredients in FDA-approved prescription drugs used to treat erectile dysfunction, but they are not listed on the product labels. Consumers should contact their healthcare provider or pharmacist for guidance regarding these products and return any unused portions to the place of purchase for a refund.

Risk

These undeclared ingredients can pose a serious health risk because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous or life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and are at higher risk of serious adverse effects.

What You Should Do

  1. Check your supplements for the following products: RHINO 7 Platinum 5000 (UPC 617135861224), PapaZen 3300 (UPC 718122032587), FIFTY SHADES 6000 (UPC 4026666146056), or grande X 5800 (UPC 640793555440).
  2. For PapaZen 3300, specifically look for Lot# NSS050888 with an expiration date of 05-2018; for all other listed products, all lots are affected.
  3. Stop using these products immediately and contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using these drug products.
  4. Return any unused product to the pharmacy or place of purchase for a full refund.
  5. Contact Gadget Island, Inc. at their Newark, California location for further instructions regarding the return of these products.
  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

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy 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: RHINO 7 Platinum 5000 (1-capsule packet)
Model:
Recall #: D-0103-2018
UPC Codes:
617135861224
Lot Numbers:
All Lots
Product: PapaZen 3300 (1-capsule packet)
Model:
Recall #: D-0104-2018
UPC Codes:
718122032587
Lot Numbers:
NSS050888 (Exp 05-2018)
Date Ranges: 05-2018
Product: FIFTY SHADES 6000 (1-capsule packet)
Model:
Recall #: D-0105-2018
UPC Codes:
4026666146056
Lot Numbers:
All Lots
Product: grande X 5800 (1-capsule packet)
Model:
Recall #: D-0106-2018
UPC Codes:
640793555440
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78151
Status: Resolved
Manufacturer: Gadget Island, Inc
Sold By: Fifty Shades; FX Power; Express Pac Trading; Grande X
Manufactured In: United States
Units Affected: 4 products (925 1-capsule packets; 89 1-capsule packets; 273 1-capsule packets; 198 1-capsule packets)
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.

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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.