APEXXX tablets recalled for containing unapproved sildenafil
Nuway Distributors is recalling APEXXX tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.
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
Nuway Distributors, LLC is recalling APEXXX tablets, 300 mg, packaged in 1-count blister cards. The product was marketed as a dietary supplement but was found to be tainted with sildenafil, an FDA-approved drug for the treatment of male erectile dysfunction. Because the product contains an unapproved drug, it is considered an unapproved drug rather than a dietary supplement.
The recall involves 100,000 blister cards. All lots are affected. The product was sold exclusively to Ace Distributors, LLC in Orlando, FL, a retail store that sells directly to owners of gas stations, convenience stores, and smoke shops, where it can be further distributed nationwide.
Consumers who have purchased APEXXX tablets should stop using the product and return it to the place of purchase for a refund or contact Nuway Distributors, LLC for further instructions.
The recalled product
- Product
- APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
- Manufacturer
- Nuway Distributors, LLC
- Category
- Drug — Unapproved Drug
- Affected units
- 100,000
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
Distributed nationwide across the United States.
Related recalls
Same hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04
Similar recalls
- SevereNUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients
FDA (Drugs) · 2023-05-10
- CriticalProtein Shoppe Recalls Red-E Tablets Tainted With Sildenafil
FDA (Drugs) · 2020-09-30
- CriticalFDA Recalls Unapproved Zhonghua Niubian Tablets Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereUnapproved herbal capsules containing sildenafil recalled by FDA
FDA (Drugs) · 2018-02-07
- SevereAvaphinal Maximum Male Enhancement Pills Recalled for Undeclared Drug
FDA (Drugs) · 2022-03-23
- CriticalFDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil
FDA (Drugs) · 2014-04-16