APEXXX tablets — Class I drug recall D-0667-2016
Ongoing recall by Nuway Distributors, LLC, reported 2016-02-24, distributed nationwide. Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be t
| Recall number | D-0667-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuway Distributors, LLC, Orlando, FL, United States |
| Recall initiated | 2015-12-23 |
| Classified | 2016-02-16 |
| Reported by FDA | 2016-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 100,000 blister |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00705105963617 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0667-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.