Stop Using This Supplement Immediately, FDA Warns

An undisclosed addition to the supplement may put users at risk for serious heart issues.

As summer draws ever nearer and restrictions are lifted throughout the U.S., many people are eager to shed a few pounds they've gained over the course of the pandemic before resuming life as usual. However, if you've added one particular supplement to your routine to aid your weight loss efforts, you could be putting your heart in harm's way. Read on to discover which supplement the U.S. Food & Drug Administration (FDA) is warning consumers not to take due to serious health concerns.

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The FDA just announced the recall of an over-the-counter weight loss supplement that can cause serious heart issues.

man holding his chest in pain indoors.

On May 12, the FDA announced that Hi-Tech Pharmaceuticals, Inc. had voluntarily recalled a single lot of its Lipodrene w/25mg Ephedra Extract Dietary Supplement.

The lot of supplements in question was pulled from the market after it was discovered that the pills were potentially contaminated with 1,4-dimethylamylamine (DMAA). The stimulant can present severe cardiovascular risks to consumers, as it can constrict arteries and blood vessels.

The FDA notes that taking DMAA can lead to serious health issues, including arrhythmias, a spike in blood pressure, shortness of breath, chest tightening, and heart attack.

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The use of DMAA is illegal in dietary supplements.

Man taking pills in bed
iStock/Jelena Danilovic

While DMAA was once used as a decongestant, use in dietary supplements is illegal, according to the FDA.

"When DMAA is added to a product marketed as a dietary supplement, the FDA considers it to be an unsafe food additive," the FDA states. Though DMAA has been described as natural and plant-based by many companies that have included it in their formulations in the past, the FDA denies having any proof that it is found in nature. Furthermore, the FDA states that "no medical use of DMAA is recognized today."

The FDA says you should stop using the supplements "immediately."

Sick young woman taking pills while sitting on the sofa at home

While there had been no reported illnesses associated with the supplement at the time the recall notice was issued, the FDA recommends that anyone with the products at home "stop using this lot of product immediately and return it to the place of purchase for a full refund." All affected supplements—which were sold in brick-and-mortar locations in the U.S. and Puerto Rico, as well as online—come from Lot # 001211197, which is printed on the bottom of the bottle.

Individuals with questions about the recall can contact Hi-Tech Pharmaceuticals Inc. at 888-855-7919 between 9 a.m. and 5 p.m. EST, or via email at [email protected]

The supplement's manufacturer has attempted to lift prohibitions on DMAA in the past.

Caucasian woman holding gavel

In light of the health issues DMAA has been associated with, both a federal district court and the U.S. Court of Appeals for the Eleventh Circuit have deemed supplements containing DMAA unfit for human consumption.

However, the FDA reports that Hi-Tech Pharmaceuticals, the manufacturer of the recalled Lipodrene, petitioned the Supreme Court to reexamine the lower courts' decisions in 2020. Their request was subsequently rejected.

RELATED: If You Take This Popular Vitamin, Stop Immediately, FDA Warns.

Sarah Crow
Sarah Crow is a senior editor at Eat This, Not That!, where she focuses on celebrity news and health coverage. Read more
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