Premium OrgaZEN 7000 capsule — Class I drug recall D-0641-2021
Ongoing recall by NSNY Distributor Inc, reported 2021-07-07, distributed nationwide. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
| Recall number | D-0641-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NSNY Distributor Inc, Flushing, NY, United States |
| Recall initiated | 2021-04-08 |
| Classified | 2021-06-28 |
| Reported by FDA | 2021-07-07 |
| Distributed | Nationwide (US) |
| Quantity | 2,600 capsules |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00040232325557 |
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 for recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
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-0641-2021. 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.