FDA Drug recall D-0646-2017
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distribut…
- FDA Drug
- Class I
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class I recall of XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distribut… by Organic Herbal Supply, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0646-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-02-16 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Organic Herbal Supply |
| Distribution | US |
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
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).
Identifiers
| upc | 680474228768 |
|---|---|
| code_info | All lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0646-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.