Agency classClass IOur severity:Critical FDA (Drugs)·D-0642-2021·Announced 2021-07-07

Ginseng Power 5000 Capsules Recalled for Undeclared Prescription Drug Ingredients

NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.

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: The FDA classified this recall as Class I, which per the severity rubric automatically results in a Critical (5) rating. Class I recalls involve products marketed without approved applications that contain undeclared prescription drug ingredients—a serious safety violation.

Plain-English summary

NSNY Distributor Inc is recalling all lots of Ginseng Power 5000 capsules (1-count per blister card, UPC 0 40232 18144 3, manufactured by GS Natural Co, Los Angeles, CA 90010) distributed nationwide in the United States.

The product was marketed and sold without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) from the FDA. Testing found that the capsules contain undeclared sildenafil and/or tadalafil—prescription medications used to treat erectile dysfunction and pulmonary hypertension. These ingredients were not listed on the product label and were not approved for inclusion in this supplement.

Consumers who have purchased this product should not use it and should consult their healthcare provider if they have already taken it, particularly if they are taking other medications or have underlying health conditions that could interact with these undeclared prescription drugs. The product should be discarded or returned to the place of purchase.

The recalled product

Product: Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Manufacturer: NSNY Distributor Inc
Category: Drug — Supplement / Herbal Product
Hazard: undeclared-prescription-drug
sildenafil
tadalafil
unapproved-drug
Affected units: 399

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
Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2021-07-07

Same hazard · undeclared prescription drug