CLASS I Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
XtraHRD Natural Male Enhancement Capsules recalled
Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 2, 4, distributed nationwide in the US. The recall was initiated on 16 Feb 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0646-2017
- FDA event ID
- 76511
- Recalling firm
- Organic Herbal Supply, Roseville, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 Feb 2017
- FDA classified
- 5 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
Timeline
| 16 Feb 2017 | Recall initiated by company | |
| 5 Apr 2017 | Classified by FDA | +48 days |
| 12 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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
Where it was distributed
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
Stores named: Amazon, Online Retailers
Questions about this recall
Is XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 2, 4 recalled?
Yes. Organic Herbal Supply recalled XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 2, 4 on 16 Feb 2017. The recall is Class I and its status is Terminated. Recall number D-0646-2017.
Why was it recalled?
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).
Which lots are affected?
All lots
Where was it sold?
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Organic Herbal Supply
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|---|---|---|---|---|---|
| Drug | CLASS I | BIGnHARD Male Enhancement Herbal Dietary Supplement recalled | Organic Herbal Supply | Labeling Errors | Nationwide |
| Drug | CLASS I | Zrect for Women Herbal Dietary Supplement Capsules, 500 mg recalled | Organic Herbal Supply | Labeling Errors | Nationwide |
| Drug | CLASS I | Tornado Male Enhancement Herbal Dietary Supplement Capsules recalled | Organic Herbal Supply | Labeling Errors | Nationwide |
| Drug | CLASS I | Zrect Male Enhancement Herbal Dietary Supplement Capsules recalled | Organic Herbal Supply | Labeling Errors | Nationwide |
| Drug | CLASS I | Uproar All Natural Male Enhancement Herbal Dietary recalled | Organic Herbal Supply | Labeling Errors | Nationwide |