CLASS I Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
Tornado Male Enhancement Herbal Dietary Supplement Capsules recalled
Organic Herbal Supply is recalling Tornado Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied, distributed nationwide in the US. The recall was initiated on 18 Apr 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-0966-2017
- FDA event ID
- 77055
- Recalling firm
- Organic Herbal Supply, Roseville, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Apr 2017
- FDA classified
- 11 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 18 Apr 2017 | Recall initiated by company | |
| 11 Jul 2017 | Classified by FDA | +84 days |
| 19 Jul 2017 | Published in enforcement report | +8 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; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Product as listed by the FDA
TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959
Where it was distributed
Nationwide via internet
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Which lots are affected?
All lots and package sizes
Where was it sold?
Nationwide via internet
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 77055This product is part of a recall event; the main page for the event is ZDaily Daily Testosterone and Llibido Booster Herbal recalled.
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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 | 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 |
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