Male Enhancement Drugs Recall 2021: 'Thumbs Up 7' Products Tainted With Undeclared Drugs

Two companies are voluntarily recalling "Thumbs Up 7" brands of male sexual enhancement products found containing undeclared drugs that may pose serious health risks.

Antoto-K and Bit & Bet are recalling "Thumbs Up 7 Red 70K" and "Thumbs Up 7 Blue 69K," respectively after the products were found tainted with undeclared sildenafil and tadalafil, the Food and Drug Administration (FDA) said on two separate Twitter posts Tuesday.

The Thumbs Up 7 products, marketed as dietary supplements for male sexual enhancement, contain sildenafil and tadalafil that make them "unapproved new drugs," according to the FDA.

Sildenafil and tadalafil are known as phosphodiesterase (PDE-5), which can actually interact with certain prescription drugs. This means that someone with a medical condition may experience a serious reaction if they take the supplements, not knowing about the undeclared ingredients.

"For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening," the FDA explained. "Consumers with diabetes, high blood pressure, or heart disease often take nitrates."

Bit & Bet and Antoto-K have not received any reports of adverse effects related to the recalls, but they are notifying their customers by email.

Both Thumbs Up 7 products affected by the recalls were sold online across the U.S., and those who may still have them are being advised to stop using and to discard or destroy them.

Those with questions about the recall may contact Bit & Bet at (201) 208-2836 and Antoto-K at ngtbtr.k17@gmail.com.

FDA Warning

In December, the FDA released a warning for consumers to avoid purchasing close to 50 male enhancement and weight loss products sold online because they were found to have hidden ingredients that may pose health risks.

"Even if a product is not included in the list, consumers should be cautious about using certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding, sleep aids or pain relief," the FDA said then. "Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true."

Consumers may find some of the FDA's notices on tainted sexual enhancement products here.

Having hidden ingredients has increasingly become a problem in sexual enhancement drugs, the FDA said, urging consumers to be on the lookout for such tainted products.

"Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients," the FDA said. "Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market."