The FDA yanked millions of Valsartan pills off pharmacy shelves after discovering they were tainted with NDMA—a chemical better known for fueling rocket fuel and lab-induced tumors than lowering blood pressure. What started as a recall quickly spiraled into a legal maelstrom involving international drug manufacturers, tainted supply chains, and thousands of Americans now questioning whether their medication caused something far worse than high blood pressure.
If contaminated Valsartan exposed you or someone close to you to serious health risks, you’re not alone—and you’re not without options.
At LitigationConnect, our network of lawyers works directly with individuals impacted by this pharmaceutical disaster. Call (833) 552-7274 today or contact us online—your local lawyer will evaluate your claim and help you take the next step.
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Background
Let’s rewind to 2018, when regulators discovered that several batches of Valsartan, a generic drug used to treat high blood pressure and heart failure, were contaminated with NDMA. NDMA belongs to a class of compounds known as nitrosamines, some of which are used in rocket fuel, others studied for their cancer-causing potential in lab animals. It’s not something you want in your morning medication.
Discovery of Contamination
The contamination originated from active pharmaceutical ingredients (APIs) manufactured overseas—primarily by Zhejiang Huahai Pharmaceutical Co. in China and Hetero Labs in India. These companies supplied Valsartan to a long chain of drugmakers and distributors, many of whom slapped their own labels on the pills and sent them off to U.S. pharmacies. According to FDA records, the NDMA contamination appeared during a change in the manufacturing process—specifically when solvents and chemical reactions were altered to cut costs or improve yields.
FDA Recalls
Once the FDA confirmed the presence of NDMA, it triggered a domino of recalls beginning in July 2018. These weren’t minor PR cleanups. Some of the country’s largest pharmaceutical distributors were forced to pull entire inventories of Valsartan off the shelves. The agency labeled the issue a Class I recall—the most serious kind, reserved for products that pose a direct risk of serious health consequences or death.
The FDA's enforcement actions escalated quickly. Warning letters went out. Import alerts were issued. Inspections were intensified. Yet even with all this, the contamination had already reached patients who had no idea their prescribed medication was doubling as a toxic exposure experiment.
Legal Grounds for the Valsartan Lawsuits
Product Liability Claims
At the heart of the Valsartan lawsuits are product liability claims—more specifically, strict liability under product defect theories. Plaintiffs don’t need to prove intent or even negligence. They only need to show that the drug was defective when it left the manufacturer’s control and that defect led to harm. In this case, the defect was the presence of NDMA.
Under New Jersey’s Product Liability Act (N.J.S.A. 2A:58C-1 et seq.), where the current MDL is being litigated, manufacturers are held strictly liable if the product:
- Deviated from the design specifications or performance standards,
- Failed to contain adequate warnings or instructions,
- Or was designed in a way that made it unreasonably dangerous.
Valsartan checks all three boxes. The contamination wasn’t part of the original FDA-approved drug formulation. The manufacturers didn’t warn anyone. And the re-engineered production process introduced a risk that no patient signed up for.
Failure to Warn
When a manufacturer knows—or should know—about a danger, it must promptly update the warning label or issue alerts to the medical community. Plaintiffs allege that didn’t happen fast enough, or clearly enough, to prevent real harm.
Add to that the reality that many patients didn’t even know who manufactured their generic drug, thanks to repackaging and relabeling by third parties. That murkiness only deepens the liability. Courts have repeatedly ruled that ignorance of a danger—especially one created by your own supply chain—isn’t a defense when public health is at stake.
Health Implications Linked to Contaminated Valsartan
NDMA isn’t harmless in small doses—it’s a known laboratory carcinogen for a reason. This is where things get messy: linking a chemical exposure to a cancer outcome isn’t like proving a slip and fall. But when thousands of people experience eerily similar outcomes after taking the same contaminated drug, the legal system takes notice.
Cancer Risks
NDMA has a rap sheet. The World Health Organization classifies it as a Group 2A carcinogen, meaning it’s “probably carcinogenic to humans.” That’s based on decades of animal studies showing tumors in the liver, kidneys, lungs, and gastrointestinal tract. The Environmental Protection Agency set its lifetime exposure limit for NDMA in drinking water at 0.0000007 mg/L. Compare that to the levels detected in recalled Valsartan tablets—some samples contained up to 17 micrograms per pill. Taken daily, that’s years of exposure far above acceptable limits.
Patients are now stepping forward with claims that the drug didn’t just treat their hypertension—it seeded the ground for a far more aggressive illnesses such as:
- Liver cancer
- Kidney cancer
- Colorectal cancer
- Stomach cancer
Plaintiffs are backed by toxicology reports, medical studies, and pharmacovigilance data. These cases won’t hinge on proving NDMA causes cancer in general. They’ll turn on whether NDMA-laced Valsartan, taken regularly over time, materially increased a person’s risk. That’s the legal burden under general and specific causation, and it’s what plaintiffs are preparing to prove.
Other Health Concerns
Cancer isn't the only fallout. NDMA is a hepatotoxin, which means it damages the liver—even without causing cancer. People who didn’t develop tumors but did suffer from liver inflammation, elevated enzyme levels, or other unexplained health shifts may also qualify for legal claims. Long-term NDMA exposure has also been linked to:
- Abdominal pain
- Nausea and vomiting
- Jaundice
- Fatigue and malaise
Even for patients who haven’t received a cancer diagnosis, a history of Valsartan use combined with ongoing symptoms may still justify legal action, especially when medical records show no other clear cause. Plaintiffs don’t have to wait for a worst-case scenario to have a case. If the drug made them sick—or scared them into invasive medical testing—that's enough to land them in court.
Current Status of Valsartan Litigation
While the science behind the lawsuits builds the foundation, the courtroom is where everything unfolds. And right now, the action is centered in New Jersey.
The U.S. Judicial Panel on Multidistrict Litigation consolidated Valsartan cases into MDL No. 2875, assigned to Judge Renée Marie Bumb in the District of New Jersey. That’s where over 1,300 federal lawsuits sit—stacked, sorted, and prepped for a series of test trials designed to set the tone for what’s coming next.
Multidistrict Litigation (MDL)
MDLs aren’t class actions. Each plaintiff maintains an individual claim, but the court handles them collectively for pretrial motions, discovery, and other common issues. This streamlines the process, avoids contradictory rulings, and saves everyone time—especially when hundreds of lawsuits name the same defendants and raise the same legal theories.
In the Valsartan MDL, the plaintiffs allege defective design, manufacturing negligence, and failure to warn. The litigation involves not only branded manufacturers, but also generic producers, repackagers, and distributors. Each defendant has different levels of involvement, different legal strategies, and different degrees of exposure. Sorting through that requires thousands of documents, expert reports, and witness testimony—all of which are underway.
As of early 2025, the litigation remains active and fully engaged in discovery, depositions, and motions. The court has denied several defense motions to dismiss, signaling that the plaintiffs have presented enough to proceed to trial.
Bellwether Trials
Bellwether trials are the first major test. They don’t decide the fate of every case, but they serve as a legal litmus test—how real juries respond to real claims. The first one is slated for late 2025. It’ll set expectations, not just for damages, but for whether defendants want to risk a full jury trial or move toward settlement.
These cases are being selected for their representativeness—plaintiffs with long-term Valsartan use, cancer diagnoses, and documented NDMA exposure. The trial will involve expert testimony on causation, internal memos from manufacturers, and cross-examination of pharma executives who signed off on quality checks.
If juries find in favor of plaintiffs and award significant damages, it increases the pressure on defendants to settle. If juries side with defendants, it sharpens the path for which claims move forward.
For now, the courts are busy, the lawyers are locked in, and the first major rulings are months away. But the machine is moving—and once it starts handing down verdicts, the ripple effects will spread fast.
Defendants in the Valsartan Lawsuits
The Valsartan litigation names dozens of defendants, each with a different role in the chain of contamination and distribution. And the court isn’t letting any of them off the hook without a fight.
Manufacturers
At the center are two repeat names that we mentioned earlier: Zhejiang Huahai Pharmaceutical Co. (China) and Hetero Labs Limited (India). These companies were among the largest global suppliers. According to FDA inspection records and warning letters, their facilities failed to implement proper quality control standards, ignored red flags in chemical synthesis, and let NDMA levels spiral out of control.
Zhejiang Huahai, in particular, took the heat for shifting its production process in 2012 without adequately testing for nitrosamine formation. That tweak—intended to boost efficiency—unintentionally allowed NDMA to form during synthesis. Internal emails and regulatory filings now under discovery suggest the company knew about risks years before the recalls.
Under U.S. law, foreign manufacturers who knowingly introduce defective products into the domestic stream of commerce are subject to product liability suits under both federal jurisdiction and state laws like New Jersey’s Products Liability Act. Courts have held that geographic distance doesn’t matter when the effects land in American hospitals and homes.
Distributors and Repackagers
But the liability doesn’t stop overseas. Dozens of U.S.-based companies bought those contaminated APIs, pressed them into pills, repackaged them, and distributed them under a buffet of brand names. Companies like Teva Pharmaceuticals, Torrent Pharma, Major Pharmaceuticals, and Solco Healthcare all face lawsuits for their role in pushing these drugs into the market.
Their legal exposure flows from two theories:
- Failure to test: Plaintiffs argue that these companies didn’t independently test the ingredients they received—or worse, ignored test results that showed NDMA contamination.
- Labeling and warnings: Many didn’t update labels, didn’t notify consumers, and didn’t issue recalls until the FDA forced their hand.
In some cases, pharmacies dispensed Valsartan under generic names from repackagers who had no clue—or claimed they had no clue—where the original ingredients came from. That’s a chain of custody issue. But the law doesn’t care who wrote the last label. If your name’s on the bottle, and the contents are toxic, liability follows.
Don’t Let a Contaminated Pill Define Your Future
No one signs up for cancer when they refill a blood pressure prescription. But that’s exactly what happened to thousands of people across the country. And the companies responsible aren’t going to take accountability unless someone forces their hand.
If Valsartan put your health at risk, now is the time to act.
At LitigationConnect, our network of lawyers is already fighting for people just like you. Call (833) 552-7274 today or contact us online—a local attorney will evaluate your case and help you take the next step toward real accountability.