FDA Recalls Virilis Pro Dietary Supplement for Unapproved Drug Ingredients
Haute Health is recalling Virilis Pro dietary supplements because they may contain unapproved active ingredients found in FDA-approved 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 severity score of 5 according to the rubric.
Plain-English summary
Haute Health, LLC is recalling Virilis Pro, a dietary supplement packaged in 1 and 2 capsule blister packs and 10 capsule bottles. The product is manufactured in Williamstown, NJ, and was sold nationwide and internationally via the internet. The recall covers 82,944 capsules across all lot codes and expiration dates.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED), which makes the product an unapproved drug.
Consumers who have purchased Virilis Pro should stop using the product and contact Haute Health for a refund or further information. The product was distributed through internet sales channels.
The recalled product
- Product
- Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
- Manufacturer
- Haute Health, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 82,944
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 lot codes and expiration dates.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Haute Health, LLC 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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