The ExtenZe lawsuit history spans more than a decade and includes two Orange County District Attorney prosecutions, a nationwide class action, and a series of FDA safety warnings. Between 2006 and 2011, the product’s successive manufacturers agreed to pay roughly $9 million to resolve false advertising and consumer protection claims, and federal regulators have repeatedly warned that counterfeit versions of the pill contain hidden prescription drugs.
The 2006 Orange County Prosecution
The first case came in 2006, when the Orange County District Attorney’s Office settled a consumer protection action against Dish Direct, Inc., which operated as Maximizer Health Products and manufactured ExtenZe at the time. Prosecutors challenged the company’s marketing claim that the supplement could produce “up to a 27% penile enlargement,” calling it unsubstantiated.1Orange County District Attorney. OCDA To Collect $300,000 From Producers of Penile Enlargement Supplement in Consumer Protection Action
Dish Direct paid $300,000 in civil penalties without admitting fault. The settlement also required the company to stop making false or misleading advertising claims, remove lead from the pills (which prosecutors said contained lead above legally permitted levels), and improve its handling of refund requests and complaints.2Orange County Register. DA Settles Advertising Case Against Marketer of Penile Pill for $300,000
The 2010 Class Action Settlement
In 2010, a nationwide class action targeted ExtenZe’s new manufacturer, Biotab Nutraceuticals, Inc. Filed in Los Angeles County Superior Court as Williams, et al. v. Biotab Nutraceuticals, Inc., et al. (Case No. BC414808, consolidated with BC415918), the case alleged Biotab falsely claimed ExtenZe would increase penis size. Biotab denied wrongdoing.3PR Newswire. If You Bought ExtenZe, You Might Receive Money and Benefits From a Class Action Settlement
The proposed settlement, announced in October 2010, created a $6 million cash fund plus $6 million in retail value of ExtenZe-branded NASCAR merchandise. Anyone who bought ExtenZe in the United States between May 29, 2005, and October 25, 2010, was eligible to file a claim.
Claimants could choose a cash refund (which required proof of purchase) or one of two NASCAR-themed retail packages: a “Mens Retail Package” valued at $149.95, or a “His and Hers Retail Package” valued at $176.94. The deadline to file was April 15, 2011, and final approval was scheduled for March 30, 2011.4Top Class Actions. ExtenZe Class Action Lawsuit Settlement The settlement also barred Biotab from claiming its product increased penis size unless it could provide independent scientific substantiation.3PR Newswire. If You Bought ExtenZe, You Might Receive Money and Benefits From a Class Action Settlement
The 2011 Repeat Prosecution and $1.75 Million Penalty
While the class action was still being processed, the Orange County DA came after Biotab. In July 2011, prosecutors secured a $1.75 million settlement, alleging Biotab had continued making the same kinds of unsubstantiated advertising claims that had been prohibited under the 2006 injunction against its predecessor.5CBS News Los Angeles. Maker of Penis Enlargement Pills Settles Consumer Protection Case for $1.75M Biotab’s ads described ExtenZe as “the strongest, most advanced formula available to increase size and enhance sexual desire, pleasure and performance.”6East Bay Times. $1.75M Settlement in California Penis Enlargement Case
The charges went beyond advertising. Prosecutors said multiple lots of ExtenZe exceeded the legal limit of one-half microgram of lead per day without the warning labels required under California’s Proposition 65. They also alleged Biotab failed to provide timely refunds and charged customers for products they never ordered.7Quackwatch. ExtenZe Legal Actions
Biotab settled without admitting fault. The $1.75 million was earmarked for future enforcement of California’s consumer protection laws. Biotab also agreed to implement product testing protocols and to pay restitution to consumers who had filed complaints with the company, the Better Business Bureau, or the California Attorney General between July 2006 and July 2011.8Orange County Register. Diet Supplement Maker To Pay $1.75 Million
FDA Warnings About Contaminated and Counterfeit ExtenZe
Separately from the California cases, the FDA has issued a string of warnings about ExtenZe products contaminated with prescription drug ingredients that were not on the label.
In February 2011, the FDA notified Biotab that counterfeit products sold under the ExtenZe name contained hidden drugs. Testing found one lot (0709241) contained tadalafil and sildenafil, and another (0509075) contained tadalafil and sibutramine.9ConsumerLab. Recall of Counterfeit ExtenZe Tablets Containing Drugs In May 2011, the FDA issued a broader public warning about additional counterfeit lots containing tadalafil, or tadalafil combined with sildenafil.10PR Newswire. FDA Warns About Counterfeit ExtenZe Dietary Supplements Tadalafil is the active ingredient in Cialis and sildenafil is the active ingredient in Viagra; both can cause dangerous drops in blood pressure when combined with nitrates prescribed for heart disease.
In February 2012, Biotab voluntarily recalled two lots after the FDA notified it that the products contained undeclared drug ingredients. The agency stressed that authentic ExtenZe as produced by Biotab did not contain sildenafil, and that the contaminated products were counterfeits. In November 2013, the FDA warned about a counterfeit “ExtenZe Maximum Strength” (lot 0512058) that tested positive for sildenafil.11NBC News. FDA Warns Against Counterfeit Male Sexual Enhancement Product
In August 2018, the FDA issued a public notification about “Extenze Plus” (Lot H061084, expiration 12/2020) after laboratory analysis confirmed it contained sildenafil. The agency found the product during an examination of international mail shipments and advised consumers not to purchase or use it.12U.S. Food and Drug Administration. Public Notification: Extenze Plus Contains Hidden Drug Ingredient
What This Means If You Bought ExtenZe
The claim deadline for the 2010 class action passed on April 15, 2011, so that settlement is closed. If you filed a complaint about Biotab with the company, the Better Business Bureau, or the California Attorney General between July 2006 and July 2011, you were within the group eligible for restitution under the 2011 California settlement.
If you have a bottle labeled ExtenZe or Extenze Plus, check the lot number against the FDA notifications above before using it. The FDA has taken the position that authentic Biotab-produced ExtenZe did not contain sildenafil and that the contaminated pills were counterfeits, but the agency has also confirmed contamination in products sold under the ExtenZe name across multiple years and lots. Sildenafil and tadalafil interact dangerously with nitrate heart medications, so a hidden dose in a product marketed as a supplement is a real risk if you take any nitrate drug.