Agency classClass IOur severity:Critical FDA (Drugs)·D-0641-2021·Announced 2021-07-07

Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall for a drug product marketed without approval and containing undeclared prescription ingredients. Class I recalls are automatically assigned a severity score of 5 (Critical) per the rubric.

Plain-English summary

NSNY Distributor Inc is recalling Premium OrgaZEN 7000 capsules (1-count per blister card, UPC 0 40232 32555 7), distributed by Nutra Vita Co of Santa Fe Springs, California, and made in the USA. Approximately 2,600 capsules are affected across all lot codes.

The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sildenafil and/or tadalafil. These are prescription medications that can cause serious adverse effects, especially in individuals taking certain other medications or with underlying health conditions.

Consumers who have purchased this product should discontinue use immediately and consult their healthcare provider if they have taken it, particularly if they have experienced any unusual symptoms or are on other medications. Healthcare providers should report any adverse events associated with this product to the FDA.

The recalled product

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
Manufacturer: NSNY Distributor Inc
Category: Drug — Unapproved Drug / Undeclared Pharmaceutical Ingredients
Hazard: undeclared-sildenafil
undeclared-tadalafil
unapproved-drug
Affected units: 2,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

all lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by NSNY Distributor Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · NSNY Distributor Inc

See all →

Critical
Ginseng Power 5000 Capsules Recalled for Undeclared Prescription Drug Ingredients
FDA (Drugs) · 2021-07-07

Same hazard · undeclared sildenafil