Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported April 12, 2017
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
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 …
Organic Herbal Supply recalled XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2,… - a critical-severity action.
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2,… was recalled by Organic Herbal Supply in April 12, 2017. Reason: Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which …. Check the official notice for the remedy. Verify recall #D-0646-2017 with the FDA Drug before acting.
The recall
Organic Herbal Supply issued this critical-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which ….
- Critical
- severity level
- Class I
- classification
- April 12, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0646-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0646-2017) was formally reported on April 12, 2017, with the manufacturer initiating the action on February 16, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Organic Herbal Supply is listed as the recalling firm, operating out of Roseville, CA. Federal records list the affected scope as 100,000 to 150,000 capsules.
The documented reason for this recall is: 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). Distribution data in the federal record shows the product reached: Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
100,000 to 150,000 capsules
Related Recalls
6
5 from same agency
Product description
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0646-2017 |
| Date reported | April 12, 2017 |
| Date initiated | February 16, 2017 |
| Recalling firm | Organic Herbal Supply |
| Firm location | Roseville, CA |
| Affected scope | 100,000 to 150,000 capsules |
| Distribution | Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0646-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Organic Herbal Supply. Units affected: 100,000 to 150,000 capsules.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2017. Severity: Critical. Recall number: D-0646-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0646-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 12, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.