FDA Recalls PremierZen Black 5000 for Unapproved Tadalafil
Hyobin LLC is recalling PremierZen Black 5000 capsules because FDA analysis detected the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.
What this means for you
Illness, injury, or structural failure has been reported. 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 corresponds to a Severe rating under the rubric. The presence of an unapproved prescription drug (tadalafil) in a supplement represents a significant health risk, potentially leading to serious adverse health consequences, especially for individuals with certain medical conditions or taking interacting medications.
Plain-English summary
Hyobin LLC is voluntarily recalling PremierZen Black 5000, a dietary supplement packaged in cardboard blisters containing one capsule per card. The product is distributed by Yolo Studio in Cliffside Park, NJ, and was sold nationwide in the United States. The recall involves 500 cards across all lots.
The recall was initiated because FDA analysis results indicated the presence of tadalafil, a prescription medication. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Tadalafil is a prescription drug used to treat erectile dysfunction and pulmonary arterial hypertension, and its presence in an unapproved supplement poses potential health risks to consumers, particularly those taking other medications.
Consumers who have purchased PremierZen Black 5000 should stop using the product immediately. They should contact the distributor or retailer for a refund or further instructions. The specific lot numbers are not listed in the source text, but the recall covers all lots of the product.
The recalled product
- Product
- PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
- Manufacturer
- Hyobin LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 500
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.
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