FDA Drug recall D-0641-2021
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 3255…
- FDA Drug
- Class I
- ongoing
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class I recall of Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 3255… by Nsny Distributor, citing marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0641-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-04-08 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nsny Distributor |
| Distribution | US |
Product
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Identifiers
| upc | 040232325557 |
|---|---|
| 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-0641-2021%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.