Severity
Critical
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Reported: February 24, 2016 Initiated: December 23, 2015 #D-0667-2016 100,000 blister cards units
Nuway Distributors, LLC issued this FDA Drug recall on February 24, 2016. Classified as Critical severity (Class I). Approximately 100,000 blister cards units are affected. The recall was issued because: Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted wi…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Drug action (record #D-0667-2016) was formally reported on February 24, 2016, with the manufacturer initiating the action on December 23, 2015. It is classified under Critical severity (Class I), with a current status of Ongoing. Nuway Distributors, LLC is listed as the recalling firm, operating out of Orlando, FL. Federal records indicate 100,000 blister cards units are affected, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 u… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
100,000 blister cards
Related Recalls
6
5 from same agency
Product Description
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Reason for Recall
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.
Details
- Recalling Firm
- Nuway Distributors, LLC
- Units Affected
- 100,000 blister cards
- 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.
- Location
- Orlando, FL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0667-2016 |
| Date reported | February 24, 2016 |
| Date initiated | December 23, 2015 |
| Recalling firm | Nuway Distributors, LLC |
| Units affected | 100,000 blister cards |
| 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. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.. Recalled by Nuway Distributors, LLC. Units affected: 100,000 blister cards.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 24, 2016. Severity: Critical. Recall number: D-0667-2016.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0667-2016) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Recall Guides
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Understanding Recall Severity Classes
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).