These Supplements May Cause "Severe Reactions," FDA Says in New Recall Notice
THE AGENCY IS WARNING THE PUBLIC OF THE NEWLY DISCOVERED HEALTH RISK.
The dietary supplement market is a big business in the U.S., with nearly 60 percent of adults aged 20 or older reporting to have taken one within the past 30 days, according to data from the Centers for Disease Control and Prevention (CDC) from 2017-2018. The prescription-free products are often a go-to for a wide range of ailments, from keeping cholesterol in check to helping secure a good night's sleep. But now, the Food & Drug Administration (FDA) has issued a new recall notice after it discovered certain supplements that could cause "severe reactions" in people who take them. Read on to see if there's a potential health risk in your medicine cabinet.
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Dietary supplements are infamously unregulated and can pose potential health problems.
Dietary supplements have become a large industry thanks to marketing that appears to offer a quick fix in the form of an easily taken pill or capsule. But while it can feel easy to put your trust into such widely available products, you may not be getting exactly what you're paying for. That's because the process by which supplements end up on the shelf is vastly different from over-the-counter (OTC) drugs and prescription medications: Unlike approved medicines, the FDA doesn't test dietary supplements before they go on sale to the public and is "not authorized to review dietary supplement products for safety and effectiveness before they are marketed."
Research has also shown that the infamously unregulated products can vary wildly in quality. According to a 2017 study published in the Journal of Clinical Sleep Medicine that tested 31 melatonin supplements, lab testing found that 71 percent contained a different dosage than the amount advertised on their labels, ranging from 83 percent less to 478 percent more. And recently, the FDA initiated a string of recalls after inspections discovered certain enhancement supplements contained undeclared ingredients that could create dangerous interactions with other medications.
The FDA has issued a new recall notice for a dietary supplement after discovering a potential health risk.
Dean Drobot / Shutterstock
Now, the agency is pulling another product from shelves due to a potential health risk. On May 6, the FDA announced that Natural Organics had issued a voluntary recall of specific packages of its NaturesPlus Keto Living Sugar Control Capsules 90 count supplements. According to the notice, the affected products come packaged in white jars with black caps and labels with orange, white, and black printing. The items were sold in the U.S. nationwide and in Kenya, Spain, Trinidad, the United Arab Emirates, and the U.K.
The recalled items can be identified by the "best by" or "BBE" (Best Before End) dates printed on the bottom of each bottle. The affected product lots include those with Product No. 82004, UPC Code 097467820043, Lots 1362073, Best By 10/2025 and 1365200, Best By 10/2025; and Product No. Ue82004, UPC Code 097467820043, Lots 1361754, BBE 10/2025 and 1364325, BBE 10/2025.
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The agency warns the recalled supplements could cause "severe reactions" in certain people.
The FDA issued the recall notice after routine testing discovered the supplements contained gluten not declared on the label. The agency warns that anyone with a wheat or gluten allergy is at risk of "risk of serious or life-threatening allergic reactions" after taking the supplement, while those with gluten intolerance "may experience minor to severe reactions" such as fatigue, upset stomach, diarrhea, skin reactions, and more.
Here's what you should do if you have the recalled supplements in your medicine cabinet.
According to the notice, there have not yet been any reports of adverse reactions or medical emergencies related to the recalled items. But the FDA advises that any customers who purchased the affected products should return the supplements to their place of purchase. Anyone with questions or concerns can also contact Natural Organics by calling 1-800-645-9500 on weekdays from 8:00 a.m. to 4:30 p.m. EDT.
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