Virilis Pro Capsules (Haute Health) – Unapproved Ingredients (2013)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Haute Health, LLC
Lot Codes / Batch Numbers
All lot codes and expiration dates.
Products Sold
All lot codes and expiration dates.
Haute Health, LLC is recalling Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manu due to Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dys. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026