Gadget Island grande X 5800 Capsules: Undeclared Drugs Risk
Gadget Island recalls grande X 5800 capsules containing undeclared drugs. These supplements may contain sildenafil, desmethyl carbodenafil, and tadalafil without approval.
Stop using this now
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Contact the company
What happened, in plain English
Gadget Island is recalling their grande X 5800 capsules because they contain undeclared active pharmaceutical ingredients like sildenafil, desmethyl carbodenafil, and tadalafil. This poses a risk of serious health issues since these drugs require FDA approval for safety. Read more at govinfonow.com/recall/41246-gadget-island-grande-x-5800-capsules-undeclared-drugs-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41246-gadget-island-grande-x-5800-capsules-undeclared-drugs-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0106-2018
Cite this page
“Gadget Island grande X 5800 Capsules: Undeclared Drugs Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41246-gadget-island-grande-x-5800-capsules-undeclared-drugs-risk. Based on FDA recall #D-0106-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0106-2018%22&limit=1).
Why it’s dangerous
These capsules contain undeclared drugs that were not approved by the FDA. Sildenafil (Viagra), desmethyl carbodenafil, and tadalafil (Cialis) can cause serious health issues like heart attacks or strokes if taken without proper medical supervision.
Who’s affected
People who bought or use the grande X 5800 capsules are affected. Those with heart conditions or who take medications that interact with these drugs are at higher risk.
How to tell if you have this one
Check for the product name 'grande X 5800 capsule' with the listed ingredients. The capsules were distributed by Grande X Ontario, CA 91745 with UPC 640793555440 across all lots.
- Brand
Gadget Island- Product
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0103-2018 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224; All Lots | 925 1-capsule packets |
| D-0104-2018 | PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587; Lot# NSS050888, EXP 05-2018 | 89 1-capsule packets |
| D-0105-2018 | FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056; All Lots | 273 1-capsule packets |
| D-0106-2018 | grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440; All Lots | 198 1-capsule packets |
What to do — step by step
Stop Using Now
Immediately stop using the grande X 5800 capsules as they contain undeclared drugs that could cause serious health risks.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0106-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0106-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.