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.
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 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
- Manufacturer
- Beamonstar Products
- Category
- Drug — Herbal Supplement
- 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 →Related recalls
Same manufacturer · Beamonstar Products
See all →- CriticalVelextra Herbal Supplement Recalled for Containing Unapproved Tadalafil
FDA (Drugs) · 2013-09-11
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