Xrect Male Enhancement Herbal Dietary Supplement Capsules — Class I drug recall D-0964-2017
Terminated recall by Organic Herbal Supply, reported 2017-07-19, distributed nationwide. Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and
| Recall number | D-0964-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Organic Herbal Supply, Roseville, CA, United States |
| Recall initiated | 2017-04-18 |
| Classified | 2017-07-11 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2018-03-09 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00680474015795 |
Product
Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
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-0964-2017. 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.