FDA Drug recall D-0821-2018
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc
- FDA Drug
- Class I
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class I recall of Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc by Ama Wholesale, citing marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for w….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0821-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-04-12 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ama Wholesale |
| Distribution | US |
Product
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Identifiers
| upc | 718122071128 |
|---|---|
| code_info | All Lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0821-2018%22
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