- A chocolate-flavored male enhancement supplement, Rhino Choco VIP 10X, is being voluntarily recalled after the Food and Drug Administration (FDA) found it contained undeclared tadalafil, a prescription drug used to treat erectile dysfunction.
- The recalled product, sold by USALESS.COM, includes 10-gram, 12-piece chocolate bars packaged in a black box with UPC 724087947668 and an expiration date of October 2027.
- The FDA warned that undeclared tadalafil poses serious health risks, especially for individuals taking nitrate medications such as nitroglycerin, as the combination can cause a sudden and dangerous drop in blood pressure.
- Severe blood pressure drops may lead to dizziness, fainting, falls, heart attack or stroke, particularly among men with diabetes, high blood pressure, high cholesterol or heart disease.
- Although tadalafil is FDA-approved for conditions including erectile dysfunction, benign prostatic hyperplasia and pulmonary arterial hypertension, it cannot legally be included in dietary supplements, which are not subject to the same pre-market approval process as prescription drugs.
A chocolate-flavored male enhancement supplement is being urgently recalled after it was found to contain tadalafil, a prescription drug used to treat erectile dysfunction (ED).
According to a notice from the Food and Drug Administration (FDA), USALESS.COM is voluntarily recalling its Rhino Choco VIP 10X product because it contains tadalafil, which was not listed on the ingredient label and is not permitted in over-the-counter dietary supplements.
The recall applies to the Brooklyn-based company’s 10-gram, 12-piece chocolate bar supplement packaged in a black cardboard box. The product bears the universal product code (UPC) 724087947668 and an expiration date of October 2027 stamped on the back of the packaging.
The FDA warned that undeclared tadalafil poses serious health risks, particularly for individuals who take nitrates commonly prescribed for chest pain, such as nitroglycerin. “The undeclared ingredient may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels,” the recall notice stated.
People with diabetes, high blood pressure, high cholesterol or heart disease are among those most likely to be affected because they are often prescribed nitrate medications. When taken together, the combination can cause a sudden and potentially life-threatening drop in blood pressure.
A sharp decline in blood pressure can lead to dizziness, fainting and falls, and in severe cases, may trigger heart attacks or strokes due to reduced blood flow to the brain and heart. Officials warn that contaminated or improperly labeled supplements containing tadalafil may expose these individuals to serious, unintended health consequences.
USALESS.com said it has “immediately removed [the product] from our online store until we are certain that the problem has been corrected.” No adverse health events have been reported in connection with the recall. Consumers who purchased the product are advised to stop using it and consult a healthcare provider if they have concerns.
Tadalafil explained: Why the FDA bars the drug from dietary supplements
Tadalafil, as per BrightU.AI‘s Enoch defines, is a medication primarily used to treat ED by enhancing blood flow to the penis. It belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors, which work by inhibiting the breakdown of cyclic guanosine monophosphate (cGMP) – a molecule that helps relax smooth muscle tissue in the penis – allowing for better blood flow and improved erections.
However, products containing tadalafil cannot be marketed as dietary supplements. Supplements are not subject to the same pre-market approval process as prescription drugs, but they are prohibited from containing undeclared pharmaceutical ingredients.
Unlike prescription medications, dietary supplements are not regulated by the FDA to the same extent. Manufacturers are not required to obtain pre-market approval, and the agency typically intervenes only after a product has been reported to pose a health risk, issuing warnings or recalls once problems are identified.
Tadalafil, while FDA-approved for specific medical uses, carries potential side effects, including headaches, indigestion, back pain, muscle aches and dizziness. The drug can also cause serious complications when combined with certain medications.
Watch this video about the FDA recalling Green Lumber for containing tadalafil.
This video is from the Daily Videos channel on Brighteon.com.
Sources include:
DailyMail.co.uk
FDA.gov
BrightU.ai
Brighteon.com
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