The Recall Desk
CriticalFDA (Drugs)·D-0966-2017·Announced 2017-07-19

Tornado Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

Organic Herbal Supply is recalling Tornado Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

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

Organic Herbal Supply is voluntarily recalling Tornado Male Enhancement Herbal Dietary Supplement Capsules. The product is supplied in 2, 4, and 10-count packages and is distributed by American Health Supplements in Chicago, Illinois. The recall covers all lots and package sizes, with distribution occurring nationwide via the internet.

The FDA initiated this recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA laboratory analysis detected the presence of undeclared tadalafil, sildenafil, and/or their analogues, as well as Flibanserin. These are prescription medications that were not listed on the product label.

Consumers who purchased Tornado Male Enhancement Herbal Dietary Supplement Capsules should stop using the product immediately. Individuals should consult their healthcare provider before taking any medication containing tadalafil, sildenafil, or Flibanserin, as these drugs can interact with other medications and cause serious health risks.

The recalled product

Product
TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959

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 and package sizes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Organic Herbal Supply 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 11 products in this recall →