If You Have This Supplement, Stop Using It Immediately, FDA Warns
This sexual enhancement product poses the risk of "serious" health consequences.
Hopeful buyers are attracted to a wide range of supplements in the marketplace that claim to boost performance in bed. But this category is unregulated, and many of the product manufacturers make broad claims without proof. So users should always exercise caution when seeking out and consuming sexual enhancement supplements. The latest reason for skepticism comes in the form of a new product recall, as a result of a possible danger to users. Here's which performance supplement is being recalled and why, plus what you should do if you already bought it.
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Junp LLC is recalling MegMan Performance Booster capsules.
The Brooklyn, New York-based company Junp LLC is voluntarily recalling a particular lot of its MegMan Performance Booster capsules, according to a notice published by the U.S. Food & Drug Administration (FDA). The affected lot number is 2010291, and the product has an expiration date of Jan. 7, 2024. The capsules are packaged in blister packs of 10 within a carton with the UPC number 8 48998 0091 2.
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The capsules are being recalled because they are tainted with Tadalafil.
The reason for the recall is that the capsules may contain Tadalafil. This is an ingredient used in products that are approved by the FDA for the treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. However, the MegMan Performance Booster capsules are not approved by the FDA, and therefore the presence of the ingredient puts the supplement in the class of unapproved drugs, "for which the safety and efficacy has not been established," according to the recall notice. This makes them subject to recall.
MegMan Performance Booster capsules were distributed online and fulfilled by Amazon from Nov. 10, 2021 until Dec. 27, 2021 across the U.S. In December, the FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay, and other retailers due to undeclared and potentially dangerous drug ingredients. It also encouraged online marketplaces to rid their platforms of these products.
Amazon notified Junp LLC that laboratory analysis had discovered the ingredient in its capsules.
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The undeclared ingredient could pose serious health risks to people with existing health problems.
The undeclared tadalafil may present "serious health risks" to users of this supplement with underlying health issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin), and this interaction can result in lowering blood pressure to "dangerous levels that may be life-threatening," according to the recall notice. People who have diabetes, high blood pressure, or heart disease often take drugs that contain nitrates. Fortunately, Junp LLC has not received any reports of health problems related to the recalled supplements so far.
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Here's how to tell if you have the recalled products at home—and what to do about it.
Junp LLC is notifying its distributors and customers through Amazon messages and is arranging for the return of all recalled products. If you already have the booster that's being recalled, stop using it now.
If you have any questions regarding the recall, contact Junp LLC by phone at 929-559-4706 on Monday through Friday from 9 a.m. to 5 p.m. EST or by email at [email protected]. If you feel you've experienced any health problems that could be related to taking these supplements, contact your doctor or health care provider right away.
Adverse reactions or quality problems related to using this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax at 800-FDA-0178.
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