FDA Drug recall D-0667-2016
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA
- FDA Drug
- Class I
- ongoing
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class I recall of APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA by Nuway Distributors, citing 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 mal….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0667-2016 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2015-12-23 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nuway Distributors |
| Distribution | US |
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
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.
Identifiers
| upc | 705105963617 |
|---|---|
| code_info | All lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0667-2016%22
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