The Recall Desk
CriticalFDA (Drugs)·D-929-2013·Announced 2013-09-11

FDA Recalls SexVoltz Herbal Supplement Containing Unapproved Tadalafil

Beamonstar Products is recalling SexVoltz All Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.

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

Beamonstar Products is recalling SexVoltz All Natural Herbal Supplement, which is packaged in 1 and 2 capsule blister packs and 4, 10, and 12 capsule bottles. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall involves 673,851 capsules distributed nationwide and internationally from January 2012 to May 7, 2013.

The FDA determined that the product contains tadalafil, the active ingredient in an FDA-approved drug used to treat erectile dysfunction. Because the product was marketed without the required approvals and contains this active pharmaceutical ingredient, it is considered an unapproved drug.

Consumers who have purchased SexVoltz All Natural Herbal Supplement should stop using the product and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
Affected units
673,851

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 (6)

  • All lots of product distributed and sold from January 2012 to May 7
  • 2013 SKUs: 626570609490
  • 827912089028
  • 626570617877
  • 626570615316
  • 626570623588

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Beamonstar Products 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 · Beamonstar Products

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