XtraHRD Natural Male Enhancement Capsules — Class I drug recall D-0646-2017
Terminated recall by Organic Herbal Supply, reported 2017-04-12, distributed nationwide. Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which i
| Recall number | D-0646-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Organic Herbal Supply, Roseville, CA, United States |
| Recall initiated | 2017-02-16 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2017-09-13 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00680474228768 |
Product
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
Reason for recall
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
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-0646-2017. 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.