Novedex XT Dietary Supplement Lawsuit | 2025 Latest Updates

Novedex XT Dietary Supplement Lawsuit Overview

Gaspari Nutrition is recalling dietary supplement Novedex XT because it contains undeclared 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase.

The FDA has informed Gaspari Nutrition that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient, and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

This nationwide recall affects all lot codes of the company’s dietary supplement product, which was marketed for increasing natural testosterone production.

Latest Novedex XT Dietary Supplement Lawsuit Updates

• January 16, 2012 – Gaspari Nutrition agreed to settle a class action lawsuit alleging improper statements on the labeling and advertising of Novedex XT, a testosterone-boosting supplement. Under the settlement, eligible consumers could receive up to $20 per bottle purchased with proof of purchase, or $10 per bottle (up to four bottles) with a sworn statement, or opt for a free bottle of Viridex XT as an alternative compensation [1].
• October 8, 2010 – Gaspari Nutrition Incorporated announced that it is conducting a nationwide recall of all Lot Codes of Novedex XT, which was marketed “for increasing natural testosterone production” and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase [2].
• October 4, 2010 – Novedex XT was discontinued by Gaspari Nutrition for domestic sales after being sold internationally and domestically to distributors, wholesalers, retail stores, and direct to consumers [3].

FDA Reports and Statistics

The Food and Drug Administration (FDA) informed Gaspari Nutrition that 3,17-keto-etiocholetriene (ATD) does not meet the definition of a dietary ingredient, putting the product in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

​The U.S. Food and Drug Administration (FDA) has identified serious adverse events associated with certain bodybuilding products labeled to contain steroid and steroid-like substances.

A review of adverse event reports submitted to the FDA between July 1, 2009, and December 31, 2016, revealed 35 cases involving men aged 20 to 48 who experienced serious liver injuries requiring hospitalization [4].

Among these cases, 16 had sufficient data to conclude a direct relationship between the liver injury and the consumption of the product(s), 13 provided laboratory results indicating a temporal relationship, and 6 supported a possible association.

Breakdown of Specific Injuries Reported:

The majority of reported adverse events involved elevated liver enzymes—alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (AlkP)—indicative of liver injury.

While specific cases were not detailed in the report, the FDA notes that anabolic steroids may cause additional serious adverse effects such as:

• abnormal lipid profiles
• mood disorders
• androgenic effects (e.g., acne, baldness, excessive hair growth in females)
• gonadal suppression (e.g., decreased sperm count, testicular atrophy)
• enlarged breasts

Regulatory Actions Taken:

In response to these findings, the FDA has taken several regulatory actions:​

• Public Notifications: The FDA has issued public notifications warning consumers about the risks associated with bodybuilding products labeled to contain steroid and steroid-like substances.
• Product Recalls: The FDA has worked with manufacturers on a voluntary nationwide recall of the products found to contain undeclared steroidal ingredients or those associated with adverse health effects.​
• Enforcement Actions: The FDA has pursued enforcement actions against companies marketing adulterated or misbranded dietary supplements, including warning letters, seizures, injunctions, and criminal prosecutions.​​

The recall specifically addresses:

• All lot codes of Novedex XT
• Product sold in blue bottles with a black cap
• Each bottle containing sixty (60) capsules
• The supplement was marketed for post-cycle therapy (PCT) and testosterone enhancement

Novedex XT Dietary Supplement Injuries & Side Effects

Potential adverse events associated with the use of anti-aromatases like ATD in Novedex XT could lead to serious health complications.

• Hormonal Disruption: Decreased rate of bone maturation and growth.
• Reproductive Issues: Decreased sperm production and infertility.
• Behavioral Changes: Aggressive behavior.
• Organ Damage: Adrenal insufficiency, kidney failure, and liver dysfunction.
• Immediate Side Effects: Hot flashes, nausea, leg cramps, muscle aches, hair thinning, headache, and numb/tingling skin.
• Sexual Function: Loss of sexual ability/interest in some men.
• Additional Risks: Higher risk for those with liver, kidney, adrenal, or prostate abnormalities.

Do You Qualify for a Novedex XT Dietary Supplement Lawsuit?

You may qualify for a Novedex XT dietary supplement lawsuit if:

• You used Novedex XT prior to its discontinuation on October 4, 2010.
• You experienced serious side effects including hormonal imbalances, reproductive issues, organ damage, or other adverse events.
• The injuries required medical treatment or ongoing care.
• You can provide documentation linking your injuries to Novedex XT use.
• You have evidence of your purchase and use of the supplement.

Evidence Required for a Novedex XT Dietary Supplement Lawsuit

To strengthen your case, you should gather:

• Medical records documenting your health issues after taking Novedex XT.
• Proof of purchase of Novedex XT (receipts, credit card statements).
• Any remaining product or packaging.
• Documentation of your medical treatments and related expenses.
• Records of any communication with the manufacturer or retailer.
• Testimonies from healthcare providers linking your condition to the supplement.

Damages You Can Recover

Compensation from a Novedex XT dietary supplement recall lawsuit can include:

• Medical expenses for treatment of injuries and ongoing care.
• Lost wages from time away from work due to your health issues.
• Pain and suffering related to physical and emotional distress.
• Long-term health impacts and loss of quality of life.
• Punitive damages in cases where gross negligence is proven.

Novedex XT Dietary Supplement Recall Information

Novedex XT was designed to provide post-cycle therapy (PCT) by reducing potential estrogen increases after a steroid cycle, while also increasing testosterone levels.

The product was sold in blue bottles with a black cap, containing sixty (60) capsules.

Recall Information:

• Manufacturer: Gaspari Nutrition
• Recall Date: October 8, 2010
• Reason for Recall: Contains undeclared 3,17-keto-etiocholetriene (ATD), which violates the Federal Food, Drug, and Cosmetic Act
• Product Description: Blue bottles with a black cap, containing sixty (60) capsules
• Distribution: Sold internationally and domestically to distributors, wholesalers, retail stores, and direct to consumers
• Discontinued: October 4, 2010 for domestic sales

One small study on fit and healthy men found that, when dosed at 300 mg per day, participants’ testosterone levels had elevated by an average of just under 90% after 8 weeks of Novedex XT use.

Statute of Limitations for Novedex XT Dietary Supplement Lawsuits

There are statutes of limitations for filing Novedex XT dietary supplement lawsuits, which vary by state. It is crucial to act promptly and consult with an attorney to ensure you file within the required timeframe, typically ranging from one to several years from the date of injury or discovery of the connection between your health issues and the supplement.

The Defective Drug Litigation Group at Schmidt & Clark, LLP is currently accepting cases in all 50 states for those affected by Novedex XT.

Related Articles:

• Off-Cycle II Hardcore Lawsuit
• GNC Dietary Supplement Litigation
• X-ROCK Dietary Supplements Lawsuit

FAQs

1. What must be proven to win a Novedex XT dietary supplement recall lawsuit?

To win a Novedex XT lawsuit, plaintiffs must prove they used the supplement, that it caused their health issues, and that the manufacturer was negligent in warning about the risks or in ensuring the safety of the product before it was sold to consumers.

2. What compensation might I receive from a Novedex XT dietary supplement recall lawsuit?

Compensation can include medical expenses, lost wages, pain and suffering, costs for ongoing medical care, and other related damages. In severe cases, compensation may also cover long-term health impacts and loss of quality of life.

3. Is there a deadline for filing a Novedex XT dietary supplement recall lawsuit?

Yes, there are statutes of limitations which vary by state. It is crucial to act promptly and consult with an attorney to ensure you file within the required timeframe, typically ranging from one to several years.

4. What does Novedex XT do?

Novedex XT was designed to provide post-cycle therapy (PCT) by reducing potential estrogen increases after a steroid cycle, while also increasing testosterone to help maintain muscle and strength gains.

5. How does Novedex affect testosterone?

Novedex works by occupying the enzyme aromatase, which prevents testosterone from being converted into estrogen. One small study showed testosterone levels elevated by an average of just under 90% after 8 weeks of use at 300mg per day.

6. What happens if men take Novedex?

Side effects can include hot flashes, nausea, leg cramps, muscle aches, hair thinning, headache, and numb/tingling skin. More seriously, a loss of sexual ability/interest may occur in some men, along with potential organ damage in high-risk individuals.

7. Who is most at risk for adverse effects from Novedex XT?

Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events from Novedex XT use.

8. How do I know if I have a nutritional supplement drug recall lawsuit?

If you or a loved one has been injured by Novedex XT or other recalled dietary supplements, you should contact a law firm specializing in defective dietary supplement recall lawsuits immediately. You may be entitled to compensation by filing a lawsuit.

9. What kind of attorney handles Novedex XT claims?

The Defective Drug Litigation Group at Schmidt & Clark, LLP specializes in representing plaintiffs in defective dietary supplement recall lawsuits. They are handling individual litigation nationwide in all 50 states.

10. How much does it cost to file a Novedex XT lawsuit?

Most product liability attorneys, including those at Schmidt & Clark, LLP, work on a contingency fee basis, meaning you pay nothing upfront and only pay if you win your case.

See all related dietary supplement lawsuits our lawyers covered so far.

Get a Free Novedex XT Dietary Supplement Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for injuries caused by Novedex XT dietary supplements. With statutes of limitations varying by state, it’s crucial to speak with an attorney as soon as possible to protect your rights.

The Defective Drug Litigation Group at Schmidt & Clark, LLP is handling individual litigation nationwide and currently accepting new cases in all 50 states.

Our law firm offers:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case

If you or a loved one has been injured by Novedex XT Dietary Supplements included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit, and we can help.

Contact us today for a Free Confidential Case Review or call toll-free 24 hrs/day at (866) 588-0600.

References:

1. https://topclassactions.com/lawsuit-settlements/lawsuit-news/gaspari-qnovedex-xtq-class-action-settlement/
2. https://www.supplysidesj.com/supplement-regulations/gaspari-recalls-product-with-atd
3. https://www.ironmagazineforums.com/threads/gaspari-nutrition-to-discontinue-halodrol-and-novedex.107287/
4. https://www.fda.gov/drugs/drug-safety-and-availability/fda-analysis-shows-body-building-products-labeled-contain-steroid-and-steroid-substances-continue