FDA Drug recall D-0382-2021
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
- FDA Drug
- Class II
- ongoing
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ by Hyobin, citing marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0382-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-06 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hyobin |
| Distribution | US |
Product
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Identifiers
| 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: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0382-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.