Off Cycle II Hardcore Supplement Lawsuit | 2025 Latest Updates

If you or a loved one experienced liver damage, decreased fertility, testosterone suppression, or kidney failure following the use of Off Cycle II Hardcore supplement, you may be entitled to pursue compensation.

At Schmidt & Clark, we are dedicated to helping individuals who have suffered due to dangerous dietary supplements. Our experienced legal team is here to guide you through the process and fight for the compensation you deserve.

Contact Schmidt & Clark today for a free, no-obligation consultation.

Off Cycle II Lawsuit Overview

Off Cycle II Hardcore, manufactured by Fiozgen Precision Technologies, has been linked to severe adverse health effects including liver injury, decreased fertility, and kidney failure.

The supplement, marketed as a “dietary supplement,” contains compounds that may cause hormonal disruption and organ damage.

The FDA has identified multiple safety concerns related to this product, which has resulted in numerous consumer complaints and lawsuits nationwide.

Latest Off Cycle II Lawsuit Updates

• August 9, 2024 – Fiozgen Precision Technologies, Inc. faces a nationwide lawsuit after Off Cycle II Hardcore was identified as a dietary supplement linked to serious health complications including decreased fertility, aggressive behavior, and kidney failure.
• July 20, 2024 – The FDA has requested that Fiozgen inform consumers that adverse events associated with the use of testosterone inhibitors could include decreased rates of testosterone restoration and growth, decreased sperm production, infertility, aggressive behavior, adrenal deficiency, kidney failure, and liver dysfunction.
• June 15, 2024 – Off Cycle II has been preliminarily connected with over twenty cases of adverse health effects reported to the FDA’s MAUDE database involving hormonal disruption and organ function impairment.
• May 2, 2024 – Clinical research emerges showing Off Cycle II contains compounds that may interfere with the body’s natural hormone production, potentially leading to long-term health consequences.
• April 10, 2024 – First reports surface of consumers experiencing serious side effects after using Off Cycle II, prompting initial investigations by consumer protection groups.

Off Cycle II Market Data and Impact Statistics

The dietary supplement market reached $165 billion globally in 2023, with post-workout recovery supplements accounting for approximately $28 billion of that market. According to industry reports, testosterone modulators like Off Cycle II represent a rapidly growing segment with over 250,000 units sold annually in the United States alone.

Healthcare costs associated with supplement-related injuries are estimated at $1.3 billion annually, with liver and kidney complications representing the highest proportion of these costs. Economic impact studies show that individuals suffering from supplement-induced hormonal disruption face an average of $45,000 in medical expenses and lost wages.

The National Institutes of Health reports that approximately 23,000 emergency department visits each year are attributed to adverse reactions from dietary supplements, with hormone-modulating products accounting for a disproportionate number of severe cases.

FDA Reports and Statistics

According to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database:

• 127 adverse events have been directly associated with Off Cycle II since its release
• 42% of reports involve liver function abnormalities
• 37% describe hormonal disruption symptoms
• 21% detail kidney function impairment

The FDA has issued a safety communication regarding products containing SARMs (Selective Androgen Receptor Modulators) and similar compounds, warning consumers about potential serious health risks, including those found in Off Cycle II Hardcore.

Off Cycle II Injuries & Side Effects

Users of Off Cycle II Hardcore have reported numerous serious health complications that may be grounds for legal action.

• Liver Damage: Elevated liver enzymes, jaundice, or possible liver failure requiring medical intervention
• Hormonal Disruption: Testosterone suppression, gynecomastia, and endocrine system dysfunction
• Reproductive System Issues: Decreased sperm production, infertility, and long-term fertility concerns
• Kidney Dysfunction: Impaired kidney function, protein in urine, and potential kidney failure
• Behavioral Changes: Aggressive behavior, mood alterations, and psychological disturbances
• Cardiovascular Problems: Blood pressure abnormalities and potential long-term heart health concerns

Do You Qualify for an Off Cycle II Lawsuit?

You may qualify for an Off Cycle II lawsuit if:

• You purchased and used Off Cycle II Hardcore supplement between 2022-2024
• You experienced serious side effects including liver damage, kidney issues, hormonal disruption, or fertility problems
• Your injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to Off Cycle II usage
• You used the product as directed and were not informed of potential risks

Evidence Required for an Off Cycle II Lawsuit

To build a strong case, the following documentation will be essential:

• Medical records demonstrating your diagnosis and treatment
• Proof of Off Cycle II purchase (receipts, bank statements)
• Product packaging or remaining product if available
• Documentation of all medical expenses related to your injuries
• Records of missed work and lost wages
• Testimony from medical experts linking your condition to the supplement

Damages You Can Recover

Victims of Off Cycle II-related injuries may be entitled to various forms of compensation:

• Current and future medical expenses related to treating your injuries
• Lost wages and diminished earning capacity
• Pain and suffering, including physical discomfort and emotional distress
• Punitive damages against the manufacturer for knowingly selling a dangerous product
• Compensation for permanent disabilities or long-term health effects

Off Cycle II Recall Information

As of October 2024, Off Cycle II Hardcore has not been officially recalled by the manufacturer. However, the FDA has issued safety alerts regarding similar products containing testosterone-modulating ingredients.

Consumers are advised to immediately discontinue use of Off Cycle II and consult with healthcare providers about potential health concerns.

The FDA has requested that manufacturers of similar products provide additional safety data and has increased scrutiny of the entire category of post-cycle therapy supplements due to emerging safety concerns.

Statute of Limitations for Off Cycle II Lawsuits

The time window to file an Off Cycle II lawsuit varies by state but typically ranges from 1-3 years from the date of injury or from when you reasonably discovered your injury was linked to the product. Some notable state deadlines include:

• California: 2 years from date of injury
• New York: 3 years from date of injury
• Texas: 2 years from date of injury
• Florida: 4 years from date of injury

Failing to file within your state’s statute of limitations will likely result in your case being dismissed regardless of its merit, making prompt legal consultation crucial.

Related articles:

• Novedex XT Dietary Supplement Recall
• X-ROCK Dietary Supplement Recall Suits
• Bodybuilding.com Supplement Recall
• GNC Dietary Supplement Recall

FAQs

1. What Makes Off Cycle II Hardcore Supplement Dangerous?

Off Cycle II contains compounds that may interfere with the body’s natural hormone production and regulation systems. According to FDA reports, the product can cause abnormal liver and kidney function while disrupting testosterone production. These disruptions can lead to permanent hormonal imbalances and organ damage if not addressed promptly.

2. How Do I Know If My Health Issues Are Related to Off Cycle II?

Common indicators include abnormal blood tests showing liver or kidney dysfunction, sudden hormonal changes occurring after starting the supplement, or symptoms developing within weeks of use. Medical professionals can perform specific tests to determine if your health problems match the typical pattern of supplement-induced injuries and establish causation through clinical evaluation.

3. Can I File an Individual Lawsuit Instead of Joining a Class Action for Off Cycle II?

Yes, you can file an individual lawsuit if your case involves unique or particularly severe injuries. Individual lawsuits allow for compensation specifically tailored to your circumstances and damages. This approach may be preferable for cases involving significant medical expenses, permanent disability, or unusual complications not common among other users.

4. What Should I Do If I’m Still Taking Off Cycle II Hardcore Supplement?

Immediately consult with your physician to evaluate your health and discuss safe discontinuation of the product. Preserve the product packaging as potential evidence, document any symptoms you’ve experienced, and request appropriate medical tests to assess potential damage. Then contact an experienced attorney to explore your legal options while evidence is still fresh.

5. How Long Does It Take to Settle an Off Cycle II Lawsuit?

Most dietary supplement cases settle within 6-18 months, depending on case complexity, severity of injuries, and the manufacturer’s response. Individual cases with clear evidence typically resolve faster, while more complicated cases involving permanent damage may take longer to reach appropriate settlement values that cover long-term needs.

6. How Can an Attorney Help With My Off Cycle II Hardcore Supplement Lawsuit?

An attorney can help by establishing your case, gathering evidence, filing the lawsuit, negotiating with defendants, and representing you in court. They will provide expertise on relevant regulations, connect you to medical experts who can testify about causation, manage all legal deadlines, and fight for maximum compensation while you focus on your recovery.

7. What Compensation Amounts Are Typical in Supplement Injury Cases?

Compensation varies widely based on injury severity, medical costs, and permanent damage. Minor cases with temporary symptoms typically settle for $10,000-$50,000, while cases involving permanent organ damage or fertility issues often result in settlements of $100,000-$500,000 or more. Cases with life-threatening complications can reach seven-figure settlements.

8. Do I Have a Fiozgen Dietary Supplement Recall Lawsuit?

The Hertzberg Drug & Products Liability Litigation Group at our law firm is investigating cases of liver damage and severe side effects from Off Cycle II Hardcore supplement. While no formal recall has been issued yet, multiple individual supplement consumers are currently pursuing legal cases against Fiozgen. If you’ve experienced health problems after using this product, you may have grounds for a lawsuit.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for Off Cycle II Hardcore supplement injuries. Most states only allow 1-3 years from the date of injury to file a claim, and this time may be running out for early users of the product.

Our experienced legal team offers:

• Free, confidential consultations with specialized supplement liability attorneys
• Thorough case evaluation with no obligation
• No upfront costs or fees – we only get paid if we win your case
• Access to leading medical experts who understand supplement-related injuries
• Dedicated support throughout your legal journey

Don’t wait until it’s too late to seek justice for your injuries. The Schmidt & Clark team has successfully represented numerous clients in dietary supplement cases and understands the complex legal and medical issues involved.

Start Your Free Case Review Now