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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Haute Health, LLC
See all →- CriticalPHUK Sexual Enhancement Supplement Recalled for Unapproved Active Ingredients
FDA (Drugs) · 2014-04-23
- SevereProlifta Dietary Supplement Recalled for Unapproved Erectile Dysfunction Ingredients
FDA (Drugs) · 2014-04-23
Same hazard · unapproved drug ingredients
See all →- SevereImperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients
FDA (Drugs) · 2021-06-23
- CriticalBiotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients
FDA (Drugs) · 2017-08-23
- CriticalMS Bionic Recalls MegaJex Herbal Supplement Containing Unapproved ED Drugs
FDA (Drugs) · 2017-02-22
- SevereBethel Advance capsules recalled for unapproved drug ingredients
FDA (Drugs) · 2013-12-25