The Recall Desk
CriticalFDA (Drugs)·D-345-2014·Announced 2013-12-18

Volcano Male Enhancement Capsules Recalled for Undeclared Pharmaceutical Ingredients

Myson Corporation is recalling Volcano Male Enhancement capsules because they contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.

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

Myson Corporation, Inc. is recalling all lots of Volcano Male Enhancement 1500mg capsules. The product is packaged in a black round plastic pop top container and was marketed as a dietary supplement. The recall includes Volcano Liquid and Volcano Capsules.

The recall was initiated because the products were found to contain undeclared active pharmaceutical ingredients. The presence of these undeclared ingredients means the products are considered unapproved new drugs rather than dietary supplements. The products were distributed nationwide.

Consumers who have purchased Volcano Male Enhancement capsules should stop using the product. The source text does not provide specific lot numbers or expiration dates, as no codes or lots are listed on the products.

The recalled product

Product
Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordycep

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)

  • No codes or lots listed on products.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Myson Corporation, 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 2 products in this recall →

Same manufacturer · Myson Corporation, Inc.

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