Attorney at Graves McLain Injury Lawyers
Practice Areas: Car Accidents, Medical Malpractice, Vaccine Injuries
The United States Food and Drug Administration (FDA) has issued several recalls for Irbesartan, a commonly prescribed blood pressure medication, due to the discovery of a chemical linked to cancer. Patients across the country who relied on this medication are now left wondering if their health has been put at risk.
If you or someone you know has taken Irbesartan, it’s essential to understand why this recall happened, what it means, and what your options are moving forward.
Irbesartan is part of a group of medications known as angiotensin receptor blockers (ARBs). Doctors prescribe these drugs to help patients manage high blood pressure and heart failure. However, specific batches of Irbesartan were found to be contaminated with N-nitroso-diethylamine (NDEA), a chemical that may increase cancer risk.
The FDA classified N-nitroso-diethylamine (NDEA) as a probable human carcinogen based on laboratory animal studies.
In 2019, Prinston Pharmaceuticals voluntarily recalled eight lots of irbesartan and irbesartan/Hydrochlorothiazide (HCTZ) tablets. The contamination was discovered during routine quality testing. Since then, other manufacturers and medications in the same class—such as Valsartan and Losartan—have also been subject to recalls.
The Irbesartan recall is part of a larger issue that began in 2018. Over several years, both the FDA and pharmaceutical companies have taken steps to remove contaminated products from the market.
According to FDA data, Irbesartan recalls began in 2018 and continued in waves due to contamination concerns affecting multiple manufacturers.
Year | Manufacturer Involved | Drug Name & Strength | Contaminant Found | FDA Action |
| 2018 | Solco Healthcare | Valsartan 160mg | NDMA | Voluntary recall |
| 2019 | Prinston Pharmaceuticals | Irbesartan HCTZ 300mg/12.5mg | NDEA | Voluntary recall |
| 2021 | Mylan Pharmaceuticals | Losartan 100mg | NDEA/NDMA | Nationwide recall |
| 2023 | Lupin Pharmaceuticals | Irbesartan 150mg | NDEA | Recall issued |
| 2024 | Ongoing Monitoring | Various ARBs | Contamination risk | FDA Safety Advisory |
NDEA, the chemical found in specific Irbesartan batches, has been shown to cause cancer in animals. While research is still ongoing in humans, the FDA considers it a probable human carcinogen.
Do not stop taking your blood pressure medication without speaking to your doctor, even if your lot number is recalled.
The risk depends on how long the contaminated drug was used and how much was taken. Some patients may experience no health effects, while others may face serious concerns, including liver damage or increased cancer risk. The FDA has warned patients not to discontinue taking their medication without medical guidance because untreated high blood pressure can be dangerous.
The FDA regulates drug safety in the U.S. When a manufacturer or the FDA identifies a contamination issue, a recall is issued to protect public health.
Product liability lawsuits involving defective drugs can help injured patients seek compensation for medical costs, lost income, and long-term health consequences.
Under federal law, patients who are harmed by defective medications may have the right to file a lawsuit. These are typically product liability cases, where the manufacturer can be held accountable for distributing unsafe or contaminated drugs. In some cases, these lawsuits are consolidated into multi-district litigation (MDL) when large numbers of people are affected.
If you took Irbesartan and later developed health complications—especially cancer—you may be eligible to take legal action. These lawsuits are designed to help injured patients recover compensation for:
Before filing a claim, it’s essential to save your medication bottles and pharmacy records. These records might be used as evidence that you were prescribed a recalled batch. It’s also helpful to gather any medical records related to your diagnosis, especially if your doctor linked your condition to the recalled medication. The more documentation you have, the stronger your potential case will be.
Irbesartan has been recalled due to contamination with N-nitroso-diethylamine (NDEA), a probable human carcinogen.
Exposure to NDEA may increase cancer risk over time. Long-term effects depend on dosage, duration, and individual health factors.
You may be eligible if you experienced significant health problems like organ damage or cancer after taking a recalled batch. A lawyer can help review your case.
Prinston, Solco, and Mylan brands have issued recalls. The FDA website maintains an up-to-date list of affected products and lot numbers.
Check the lot number and consult your doctor before stopping medication. Save all packaging and talk to a lawyer about your legal options.
The FDA issues recall when there is a verified risk to public health. Manufacturers often initiate voluntary recalls after testing shows contamination.
The Irbesartan recall is part of a wider pattern of contamination in blood pressure medications. For patients, this raises serious questions about long-term safety and whether their health has been put at risk. If you’ve taken Irbesartan and experienced complications, it may be worth looking into your legal rights.
Every case is different. Certain patients might be qualified to submit a claim. This is for compensation, especially if cancer or serious illness followed the use of a recalled product. Having your records reviewed by an experienced team is the first step toward getting answers.
Graves McLain Injury Lawyers has worked with clients across Oklahoma in pharmaceutical liability cases. With years of experience handling complex drug injury claims, their team can help you understand your legal position and whether filing a case makes sense in your situation. If you’re unsure, reaching out for a no-cost case review is a good place to begin.
When injury victims need a law firm with a reputation for excellence, turn to Graves McLain Injury Lawyers. We are a top-rated personal injury firm determined to be the best. With decades of award-winning representation, our clients recover the compensation they need to put their lives back together.
