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What’s the problem?
February 23, 2011 - This week, the U.S. Food & Drug Administration (FDA) announced that Biotab Nutraceuticals, Inc. will be recalling two lots of EXTENZE nutritional supplement tablets due to counterfeit products containing dangerous undeclared drug ingredients. More specifically:
- lot 0709241 contains tadalafil and sildenafil
- lot 0509075 contains tadalafil and sibutramine
The counterfeit products are sold at the retail level nationwide in the form of carded four-packs (lot 0709241) and in the form of a box of thirty tablets divided into two fifteen-tablet blister packs (lot 0509075).
Why are These Drugs Dangerous?
Typically used to treat erectile dysfunction (ED), tadalafil and sildenafil may interact with some nitrates and lower blood pressure to dangerous levels. Individuals with diabetes, high blood pressure/cholesterol, or heart disease often take nitrates.
Sibutramine was withdrawn from the market in October 2010 because it has been found to present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
It is important to note that the counterfeit Extenze product is not manufactured, distributed, or packaged by Biotab, but is falsely marked with the same lot numbers used by the genuine product. Because it is difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this recall of the two affected lots. It is possible that there may be other counterfeit products on the market that have yet to be identified.
What Happens if You Take Too Many Extenze?
A 2016 case study found that unregulated overuse of sildenafil, which has been found in ExtenZe, can lead to symptoms including seizures, memory loss, high blood sugar, and loss of nerve function.
A 2017 case study diagnosed a rare type of heart failure in a man who had overdosed on yohimbine, an ingredient contained in ExtenZe.
A 2018 public notification from the FDA advised against using ExtenZe.
A 2019 case study found that active ingredients and hormones contained in ExtenZe could increase your risk of developing gynecomastia, a condition characterized by the over-development or enlargement of the breast tissue in men or boys.
“There’s currently no clinical evidence to suggest that ExtenZe could help or improve erectile dysfunction, enhance sexual performance, or increase penis size,” said Jillian Kubala, a registered dietitian.
FDA Press Release on EXTENZE
If you’d like more specific information about this nationwide recall, please visit the FDA website  to view the official press release.
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Do I have an Extenze Lawsuit?
The Product Liability & Defective Drug Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Extenze lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.