PrimeZEN Black 6000 Capsule Recalled for Undeclared Pharmaceutical Ingredients
The FDA is recalling PrimeZEN Black 6000 capsules distributed nationwide because they contain undeclared sildenafil and tadalafil. The product is unapproved and was marketed without FDA authorization.
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: This product has been classified as FDA Class I. Per the severity rubric, FDA Class I recalls are never scored below 4. The source text does not report deaths, hospitalizations, or confirmed injuries, preventing a Critical designation.
Plain-English summary
The FDA is recalling PrimeZEN Black 6000 capsules, a male sexual performance enhancement product distributed by Prime Premier Group, Los Angeles, California. The recalled product consists of 2,000mg capsules in 1-count blister cards with Lot Number NPINPB 1003, UPC 7 28175 52189 1, and expiration date of August 16, 2025. The product was distributed nationwide in the United States.
FDA analysis found that the product contains undeclared sildenafil and tadalafil, pharmaceutical ingredients that are found in FDA-approved products for male sexual enhancement. The product was marketed without approval. Specifically, there is no approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for this product, making it an unapproved drug.
The recalled product
- Product
- PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
- Manufacturer
- Volt Candy Wholesale Club
- Affected units
- 432
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 (2)
- Lot number: NPINPB 1003
- Expiration date: 08/16/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · undeclared sildenafil
See all →- SevereVitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac
FDA (Drugs) · 2024-12-11
- SevereZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
FDA (Drugs) · 2024-12-11
- SeverePeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
FDA (Drugs) · 2024-12-11
- SevereHard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
FDA (Drugs) · 2024-10-09
- SevereGold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil
FDA (Drugs) · 2024-10-09
Similar recalls
- CriticalPremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2021-06-30
- SeverePremierZEN Gold 7000 Capsule Recalled for Undisclosed Drug Contamination
FDA (Drugs) · 2021-06-30
- SevereNamoo Enterprise Recalls PremierZen Black 5000 Capsules for Unapproved Ingredients
FDA (Drugs) · 2021-05-05
- CriticalXZEN Platinum Recalled for Undeclared Erectile Dysfunction Drug Ingredients
FDA (Drugs) · 2014-09-24
- SevereFDA Recalls PremierZen Extreme 3000 for Unapproved Active Ingredients
FDA (Drugs) · 2021-05-12
- SevereMiracleZEN Platinum Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2014-05-28