The Recall Desk
CriticalFDA (Drugs)·D-0106-2018·Announced 2017-12-13

Grande X 5800 Capsules Recalled for Undeclared Prescription Ingredients

Gadget Island, Inc. is recalling Grande X 5800 capsules because they contain undeclared prescription drugs sildenafil, desmethyl carbodenafil, and tadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

Plain-English summary

Gadget Island, Inc. is voluntarily recalling 198 1-capsule packets of Grande X 5800 capsules. The product was distributed nationwide in the USA. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared active pharmaceutical ingredients.

The undeclared ingredients identified in the product are sildenafil, desmethyl carbodenafil, and tadalafil. These are prescription medications typically used to treat erectile dysfunction. The presence of these undeclared drugs poses a risk to consumers, particularly those with heart conditions or those taking nitrates, as they can cause dangerous drops in blood pressure.

Consumers who have purchased Grande X 5800 capsules should stop using the product immediately. They should contact Gadget Island, Inc. for a refund or further information. The recall covers all lots of the product.

The recalled product

Product
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, distri
Manufacturer
Gadget Island, Inc
Category
Drug — Supplement
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Gadget Island, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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