The Recall Desk
CriticalFDA (Drugs)·D-930-2013·Announced 2013-09-11

Velextra Herbal Supplement Recalled for Containing Unapproved Tadalafil

Beamonstar Products is recalling Velextra 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 Velextra All-Natural Herbal Supplement, which is packaged in 1 and 2 capsule blister packs and 4, 10, and 12 capsule bottles. The product was manufactured for Beamonstar Products in Queen Creek, AZ.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product has been found to contain tadalafil, the active ingredient in an FDA-approved product used to treat erectile dysfunction. This makes the product an unapproved drug.

The recall affects 145,632 capsules distributed nationwide in the US and internationally. All lots of the product distributed and sold from January 2012 to May 7, 2013 are included. The specific SKUs are 626570613855, 626570619055, 626570617860, and 626570617563. Consumers should stop using the product and contact the recalling firm for instructions.

The recalled product

Product
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
Manufacturer
Beamonstar Products
Category
Drug — Unapproved Drug
Hazard
Affected units
145,632

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 (5)

  • All lots of product distributed and sold from January 2012 to May 7
  • 2013. SKUs: SKUs 626570613855
  • 626570619055
  • 626570617860
  • 626570617563

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 →

Related recalls

Same manufacturer · Beamonstar Products

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Same hazard · unapproved drug

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