Unapproved Male Enhancement Supplements Containing Tadalafil Recalled Nationwide
InSo-Independent Contractor for West Coast Nutritionals, LTD is recalling three unapproved male enhancement products found to contain undeclared tadalafil.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of undeclared tadalafil, a prescription drug, in unapproved supplements represents a significant safety hazard.
Plain-English summary
InSo-Independent Contractor for West Coast Nutritionals, LTD is recalling approximately 8,000 blister packs of three male enhancement products: Firminite 805 mg, Libidron 410 mg, and Extra Strength Instant Hot Rod 496 mg. These products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and were found to contain undeclared tadalafil. Tadalafil is an FDA-approved prescription drug used to treat male erectile dysfunction, which makes these products unapproved new drugs.
The recalled products were distributed nationwide in the United States, as well as in the U.S. Virgin Islands, Puerto Rico, and numerous international locations including the United Kingdom, Canada, Australia, and various countries in Europe, Asia, Africa, and the Middle East. All lots of the affected products are included in this recall.
Consumers who have purchased these products should stop using them immediately and contact the recalling firm for a refund or further instructions. Because these products contain an undeclared prescription medication, they may pose health risks to individuals who are taking other medications, particularly those for heart conditions or blood pressure.
The recalled product
- Product
- a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is…
- Category
- Drug — Unapproved New Drug
- Affected units
- 8,000
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)
- All lots
Distribution
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