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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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
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