The Recall Desk
CriticalFDA (Drugs)·D-0105-2018·Announced 2017-12-13

Gadget Island Recalls FIFTY SHADES 6000 Capsules for Undeclared Ingredients

Gadget Island, Inc. is recalling FIFTY SHADES 6000 capsules because they contain undeclared active pharmaceutical ingredients 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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Gadget Island, Inc. is recalling FIFTY SHADES 6000 capsules, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading. The product is identified by UPC 4026666146056. The recall involves 273 1-capsule packets and affects all lots.

The recall is being conducted because the product was marketed without an Approved NDA/ANDA and contains undeclared Active Pharmaceutical Ingredients: sildenafil, desmethyl carbodenafil, and tadalafil. These ingredients are not listed on the product label.

The product was distributed nationwide in the USA. Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
Manufacturer
Gadget Island, Inc

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 →