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What’s the Problem?
This recall affects Lot # 001211197, Exp. 12/25 of Lipodrene w/25mg Ephedra Extract Dietary Supplement, according to the U.S. Food & Drug Administration (FDA) .
“The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a corresponding rise in blood pressure or other cardiovascular problems, such as Shortness of breath, Arrhythmias, Elevated blood pressure, Tightening in the chest, and Heart attack,” the agency said.
This recall was initiated after an FDA analysis found the presence of DMAA in 1 lot of Lipodrene. The supplements were purchased by and distributed through wholesale and direct sales in the U.S. and Puerto Rico, and through online sales for both personal use and retail sales.
If you purchased any dietary supplements that are affected by this recall, you should not take them, and either throw them away or return them to the point of purchase for a refund.
This recall began on May 12, 2021.
Related Article: DMAA Safety Issues Lawsuit
What is the FDA Doing to Remove DMAA Products from the Market?
In recent years, the FDA has implemented a variety of methods to ensure DMAA-containing products are removed from the U.S. market. The agency is taking these actions to protect consumers and get these products off the shelves immediately.
Beginning in 2012, the FDA issued warning letters to companies notifying them that marketing DMAA-containing products was in violation of U.S. law. When the agency finds products containing DMAA during facility inspections, it gives them an opportunity to voluntarily recall and destroy the products. When firms have chosen not to comply voluntarily, the FDA has taken other actions.
In 2013, the FDA detained 2 DMAA-containing products, OxyElite Pro and Jack3d, after USPLabs refused to voluntarily comply. USPLabs was ultimately forced to destroy the detained products, which were worth over $8 million at the retail level, and agreed to stop manufacturing with DMAA.
Also in 2013, the FDA seized DMAA-containing products from Hi-Tech Pharmaceuticals; a federal district court ruled in April 2017 that the products were adulterated and ordered them condemned and forfeited to the United States for destruction.
In 2019, the U.S. Court of Appeals for the 11th Circuit affirmed the lower court ruling, finding that DMAA is not generally recognized as safe, and condemning and forfeiting the seized articles containing DMAA. The Supreme Court denied a request from Hi-Tech Pharmaceuticals to review the case in 2020. The products were destroyed in Nov. 2020.
See all related dangerous drugs lawsuits our attorneys covered so far.
Do I Have a Lipodrene Lawsuit?
The Products Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Lipodrene Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or another loved one was harmed by the side effects of Lipodrene, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.