Virilis Pro — Class I drug recall D-1237-2014
Terminated recall by Haute Health, LLC, reported 2014-04-23, distributed nationwide. Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in s
| Recall number | D-1237-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haute Health, LLC, Williamstown, NJ, United States |
| Recall initiated | 2013-09-27 |
| Classified | 2014-04-15 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2015-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 82,944 capsules |
| Reason classes | unapproved 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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1237-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.