The Recall Desk
CriticalFDA (Drugs)·D-1603-2014·Announced 2014-09-24

Nova Products Recalls Mojo Risen Due to Undeclared Sildenafil

Nova Products, Inc. is voluntarily recalling Mojo Risen because FDA testing found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 5 according to the rubric.

Plain-English summary

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Mojo Risen, 670 mg, 2 capsule per pouch. The product is distributed by Mojo Risen, LLC in Springville, Utah. The recall is limited to Lot # 10081359.

The recall is being conducted because FDA laboratory analysis determined that the product contains undeclared amounts of sildenafil. Sildenafil is an active ingredient in FDA-approved drugs used to treat erectile dysfunction. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The product was distributed nationwide to retailers and distributors. Consumers should stop using the recalled product and contact the distributor or manufacturer for further instructions.

The recalled product

Product
MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663

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)

  • Lot# 10081359

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Nova Products, 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 8 products in this recall →