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.
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 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
- Manufacturer
- Nova Products, Inc.
- Category
- Drug — Dietary Supplement
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 →Related recalls
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