FDA Recalls Triple SupremeZen Plus 3500 for Unapproved Tadalafil
Hyobin LLC is recalling Triple SupremeZen Plus 3500 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The presence of an unapproved prescription drug (tadalafil) in a consumer product represents a significant health risk, warranting a Severe rating.
Plain-English summary
Hyobin LLC is recalling Triple SupremeZen Plus 3500, a product packaged in cardboard blisters containing one capsule per card. The product was distributed by Yolo Studio in Cliffside Park, New Jersey, and was available nationwide in the United States. The recall involves 300 cards, and all lots are affected.
The recall was initiated because FDA analysis results indicated the presence of tadalafil. Tadalafil is a prescription medication, and the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the product was sold without the required regulatory approval for its specific formulation and marketing claims.
Consumers who have purchased Triple SupremeZen Plus 3500 should stop using the product immediately. They should contact Hyobin LLC or Yolo Studio for further instructions on how to return or dispose of the product. Using unapproved products containing prescription drugs can pose health risks, particularly for individuals with certain medical conditions or those taking other medications.
The recalled product
- Product
- Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
- Manufacturer
- Hyobin LLC
- Category
- Drug — Unapproved Supplement
- Hazard
- Affected units
- 300
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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Hyobin LLC 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 3 products in this recall →Related recalls
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