If You Bought This Supplement From Walmart, Stop Taking It Now, FDA Warns
A major issue with the product could put your health at serious risk.
Just as their name suggests, supplements are marketed as a simple way to get more of the vitamins and nutrients your body needs in an easy format. But unfortunately, because of how they enter the market, you may not always get what you paid for. Studies have shown that some of the health benefits promised by these products can fall short of expectations. But besides being a waste of money, there are also some instances in which they can be potentially dangerous. Now, the Food & Drug Administration (FDA) is warning that a supplement sold by Walmart poses a potentially serious health risk. Read on to see which purportedly health-boosting pill you should stop taking immediately.
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Certain products on the market are regulated differently than medicines.
Because of how they're advertised or packaged, it can be easy to assume that the supplements you see on the shelf are regulated in the same rigorous way that over-the-counter (OTC) or prescription medicines are. But in reality, these products enter the market in a much different way than the pain relievers and cold medicines you regularly rely on.
FDA regulations currently require "dietary supplements," "herbal supplements," and any other distinctions to be labeled as such. However, products are not required to be proven safe or to verify they provide the health claims printed on the label before they can be sold. The agency says that it's only after an item hits the shelf and is purchased by the public that it will take action "against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded." And even then, the agency may be slow on the draw: It clarifies that it only reviews product labels, information, and marketing campaigns "as its resources permit."
Unfortunately, the current setup can lead to potentially risky situations for some people's health—especially if they're dealing with other conditions. "Supplements may interact with other medications you're taking or pose risks if you have certain medical conditions, such as liver disease, or are going to have surgery," Jeffrey Millstein, MD, a physician at Penn Internal Medicine Woodbury Heights, told Penn Medicine. "Some supplements also haven't been tested in pregnant women, nursing mothers, or children, and you may need to take extra precautions."
Now, the FDA is warning that one such product could pose a serious health problem.
The FDA has issued a recall for a supplement sold online by Walmart and other retailers.
On Sept. 28, the FDA announced that My Stellar Lifestyle brand operator Proper Trade LLC had issued a voluntary recall for two lots of its Wonder Pill dietary supplement. The product is marketed for use in male sexual enhancement and is packaged in 10-count blister cases that come in a carton and in a 60-count bottle.
According to the agency's notice, the recalled items were sold nationwide in the U.S. online by Walmart at Walmart.com and by Amazon. The affected products can be identified by lot numbers 20210912 or 31853-501 with an expiration date of 09/24 printed on the packaging.
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The company issued the recall due to a potentially dangerous undeclared ingredient.
The FDA reports the company pulled the product after Amazon notified them that laboratory analysis detected the products were tainted with tadalafil. The ingredient is typically used in FDA-approved drugs used to treat erectile dysfunction and belongs to a family of drugs known as phosphodiesterase (PDE-5) inhibitors. However, the discovery means that Wonder Pill is an "unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall."
The agency warns that consumers with underlying medical issues could experience "serious health risks" by unknowingly taking a product containing tadalafil. It cautions that the ingredient could interact with other prescription drugs such as nitroglycerin, leading to a dangerous drop in blood pressure that could be "life-threatening." Typically, patients with high blood pressure, diabetes, or heart disease take such nitrates to alleviate their conditions.
The latest supplement recall comes nearly two years after the FDA issued a consumer warning on Dec. 17, 2020, advising consumers to avoid nearly 50 male enhancement or weight loss products sold by online retailers such as eBay and Amazon due to "potentially dangerous drug ingredients." At the time, the press release also encouraged the companies to take steps to ensure they weren't selling the items.
Here's what you should do if you purchased the recalled supplement.
According to the FDA's notice, Proper Trade LLC has not received any reports of adverse medical events related to the recalled supplements to date. The company is also reaching out to consumers via Amazon and Walmart messages to alert them to the recall. But the agency warns customers who believe they may have purchased the affected products to stop taking them immediately.
The FDA advises anyone who may have experienced health problems after taking the affected item to immediately call their doctor or healthcare provider. Anyone with questions about the supplement recall can also contact Proper Trade LLC through the phone number or email address listed on the agency's notice.