Stop using now Drug recall · FDA · Published December 23, 2015

APEXXX 300mg Tablet Recall: Hidden Sildenafil Hazard

Nuway Distributors recalls APEXXX tablets found tainted with sildenafil. Stop using immediately due to serious health risks from unapproved drug ingredients.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0667-2016Drug APEXXX ›

Stop using this now

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.

Take action

Contact the company

Recalling firmNuway Distributors, LLC9020 Pecky Cypress Way · Orlando, FL 32836-6562

✎ GovInfoNow plain-language explainer

Nuway Distributors, LLC is recalling APEXXX tablets (300 mg) because they are tainted with sildenafil, a prescription drug for erectile dysfunction. The product was marketed as a dietary supplement but contains an unapproved drug ingredient, posing serious health risks to consumers. All lots of the 1-count blister cards are affected. Read more at govinfonow.com/recall/43308-apexxx-300mg-tablet-recall-hidden-sildenafil-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/43308-apexxx-300mg-tablet-recall-hidden-sildenafil-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-0667-2016

Cite this page

“APEXXX 300mg Tablet Recall: Hidden Sildenafil Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43308-apexxx-300mg-tablet-recall-hidden-sildenafil-hazard. Based on FDA recall #D-0667-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0667-2016%22&limit=1).

The Food and Drug Administration announced on Dec. 23, 2015, that Nuway Distributors LLC is voluntarily recalling APEXXX dietary supplement tablets because they are tainted with sildenafil, an unapproved drug ingredient. The agency classified the recall as Class I.

How to tell if you have it

APEXXX tablets, 300 mg
1-count blister cards
Distributed Exclusively by: Nuway Distributors, LLC
UPC 7 05105 96361 7

The hazard

The FDA said the APEXXX tablets are marketed as a dietary supplement but were found to contain sildenafil, an FDA-approved drug for treating male erectile dysfunction. This makes the product an unapproved drug.

Context

GovInfoNow's records show other recent recalls of similar products include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15) and Shoolin Pharma Chem Sildenafil Recall (2026-08-03). Additional recent actions involve Zydus Mirabegron 25mg Tablets Recall (2026-08-05).

How to tell if you have this one

Look for APEXXX tablets, 300 mg, packaged in individual 1-count blister cards. The UPC code is 7 05105 96361 7. The product was distributed exclusively by Nuway Distributors, LLC, and sold to Ace Distributors, LLC in Orlando, FL.

Brand
APEXXX
Product
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the product
Do not consume any APEXXX tablets found in your possession due to the risk of serious injury from hidden sildenafil.
Dispose of the tablets
Discard all remaining units safely to prevent accidental ingestion by others.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Dec 23, 2015Firm started the recall
Feb 16, 2016FDA classified it Class I
Feb 24, 2016Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/43308-apexxx-300mg-tablet-recall-hidden-sildenafil-hazard">APEXXX 300mg Tablet Recall: Hidden Sildenafil Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0667-2016 (December 23, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0667-2016 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.