MOJO RISEN Recalled for Undeclared Sildenafil and Lack of Approval
Eugene Oregon, Inc. is recalling MOJO RISEN because FDA testing found undeclared sildenafil and the product was marketed without an approved NDA or ANDA.
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 corresponds to a reasonable probability of serious adverse health consequences or death, meeting the criteria for a Critical severity score.
Plain-English summary
Eugene Oregon, Inc. is recalling MOJO RISEN, 650 mg, 2 capsule per pouch, distributed by Mojo Risen, LLC. The recall involves 57 boxes of the product, which was distributed to retailers in Maryland, Texas, Florida, Pennsylvania, Illinois, New Jersey, Indiana, Louisiana, Washington, Maine, and South Carolina.
The recall was initiated because FDA laboratory analyses determined that the product contains undeclared sildenafil. Additionally, the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased MOJO RISEN should stop using the product and return it to the place of purchase for a refund. The presence of undeclared sildenafil in a product marketed without FDA approval poses a safety risk, as sildenafil is a prescription medication with specific contraindications and potential side effects.
The recalled product
- Product
- MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
- Manufacturer
- Eugene Oregon, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 57
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
Part of a larger recall action
This product is one of 3 recalled by Eugene Oregon, 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.
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