Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Organic Herbal Supply Issue Voluntary Nationwide Recall Of All Lots Of Various Supplements For Male And Female Sexual Enhancement Due To Undeclared Tadalafil And Flibanserin

For Immediate Release

April 18, 2017

Contact

Consumers

Organic Herbal Supply
855-429-7328

Announcement

Organic Herbal Supply, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. FDA analysis has found the products to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED), the presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX. FDA analysis has found these two products contain Flibanserin, an FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women. There have been no reports of illness to date.

Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. They are packaged in 2, 4 and 10 count packages and sold nationwide. Zrect for women and LabidaMAX were packaged in 30 count packages and sold nationwide through Amazon.com and through Zrect.com. Organic Herbal began shipping this product on or around December 2014 through February 2017.

Use of these products may pose a threat to consumers because the undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Organic Herbal Supply, advises any customers in possession of the Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol, Zrect for Women, LabidaMAX to stop using and return any unused product for a full refund to the company directly. Customers can call 855-429-7328 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Organic Herbal Supply Inc. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Organic Herbal Supply Inc. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Affected Products

Product UPC
UP ROAR, ALL MALE ENHANCEMENT SUPPLEMENT, Herbal Dietary Supplement, 10 Capsules UPC #680474229260
CUMMOR, Natural Male Enhancement, 10 capsules X 500 mg, Herbal Dietary Supplement UPC #680474229116
ZRECT, Get Erect with Zrect, 10 capsules X 500 mg, Herbal Dietary Supplement UPC #852675999451
MONKEY BUSINESS, Over 4600 mg value, 12 capsules, Herbal Dietary Supplement UPC #688295456179
Xrect, X RATE YOUR LOVE LIFE, 10 capsules X 500 mg, Herbal Dietary Supplement UPC #680474015795
RECTALIS, Get MORE Out of Life, 10 capsules X 500 mg, Herbal Dietary Supplement UPC #680474228782
TORNADO, GET TANGLED IN THE SHEETS, Over 4000mg value, 10 capsules, Herbal Dietary Supplement UPC #680474228959
Z DAILY, Daily Testosterone and Libido Booster, 10 capsules X 500 mg, Herbal Dietary Supplement UPC #680474229086
BIGNHARD, BEAVERS LIKE BIG WOOD, Herbal Dietary Supplement, 10 Capsules UPC #680474229086
ENHANCEROL, Enhance your Love Life Naturally! 10 capsules X 500 mg, Herbal Dietary Supplement UPC #680474229086
ZRECT, For Women, 30 capsules X 500 mg, Herbal Dietary Supplement UPC #680474229055
LabidaMAX, INSPIRE YOUR DESIRE, Herbal Dietary Supplement, 30 Capsules UPC #680474228904

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Product Photos

  • UP ROAR,  ALL MALE ENHANCEMENT SUPPLEMENT, Herbal Dietary Supplement, 10 Capsules
  • CUMMOR, Natural Male Enhancement, 10 capsules X 500 mg, Herbal Dietary Supplement
  • ZRECT, Get Erect with Zrect, 10 capsules X 500 mg, Herbal Dietary Supplement
  • MONKEY BUSINESS, Over 4600 mg value, 12 capsules, Herbal Dietary Supplement
  • Xrect, X RATE YOUR LOVE LIFE, 10 capsules X 500 mg, Herbal Dietary Supplement
  • RECTALIS, Get MORE Out of Life, 10 capsules X 500 mg, Herbal Dietary Supplement
  • TORNADO, GET TANGLED IN THE SHEETS, Over 4000mg value, 10 capsules, Herbal Dietary Supplement
  • Z DAILY, Daily Testosterone and Libido Booster, 10 capsules X 500 mg, Herbal Dietary Supplement
  • BIGNHARD, BEAVERS LIKE BIG WOOD, Herbal Dietary Supplement, 10 Capsules
  • ENHANCEROL, Enhance your Love Life Naturally! 10 capsules X 500 mg, Herbal Dietary Supplement
  • ZRECT, For Women, 30 capsules X 500 mg, Herbal Dietary Supplement
  • LabidaMAX, INSPIRE YOUR DESIRE, Herbal Dietary Supplement, 30  Capsules

Page Last Updated: 04/19/2017
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