Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported July 19, 2017
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Organic Herbal Supply recalled BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 a… - a critical-severity action.
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 a… was recalled by Organic Herbal Supply in July 19, 2017. Reason: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil an…. Check the official notice for the remedy. Verify recall #D-0968-2017 with the FDA Drug before acting.
The recall
Organic Herbal Supply issued this critical-severity FDA Drug recall-Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil an….
- Critical
- severity level
- Class I
- classification
- July 19, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0968-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0968-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on April 18, 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. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin Distribution data in the federal record shows the product reached: Nationwide via internet. 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 - 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.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,002 dietary supplements 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
Unknown
Related Recalls
6
0 from same agency
Product description
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0968-2017 |
| Date reported | July 19, 2017 |
| Date initiated | April 18, 2017 |
| Recalling firm | Organic Herbal Supply |
| Firm location | Roseville, CA |
| Affected scope | Not disclosed |
| Distribution | Nationwide via internet |
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-0968-2017) 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? ▼
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086. Recalled by Organic Herbal Supply.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2017. Severity: Critical. Recall number: D-0968-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide via internet.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0968-2017) 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.
FDA Food Critical
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FDA Food Critical
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FDA Food Moderate
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FDA Food Low
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; N…
Winder Laboratories, LLC · 2026-03-25
FDA Food Moderate
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for t…
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Compare this recall with Blue Bull Extreme Male Enhancement Supplement, total of 15 … →
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 July 19, 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.