CLASS I ONGOING Drug recall · Reported 7 Jul 2021 · FDA Enforcement Report
Premium OrgaZEN per blister card recalled by NSNY Distributor
Nsny Distributor is recalling Premium OrgaZEN per blister card, distributed nationwide in the US. The recall was initiated on 8 Apr 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0641-2021
- FDA event ID
- 87712
- Recalling firm
- Nsny Distributor, Flushing, NY
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Apr 2021
- FDA classified
- 28 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 8 Apr 2021 | Recall initiated by company | |
| 28 Jun 2021 | Classified by FDA | +81 days |
| 7 Jul 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Which lots are affected?
all lots
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87712This product is part of a recall event; the main page for the event is Ginseng Power per blister card, GS Natural Co, Los Angeles, CA recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Ginseng Power per blister card, GS Natural Co, Los Angeles, CA recalled | Nsny Distributor | Labeling Errors | Nationwide |
More recalls from Nsny Distributor
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Ginseng Power per blister card, GS Natural Co, Los Angeles, CA recalled | Nsny Distributor | Labeling Errors | Nationwide |