What Happened to The Valsartan, Losartan, and Irbesartan Blood Pressure Medication Recall?
Beginning in 2018, a widespread recall of several angiotensin II receptor blocker (ARB) blood pressure medications, including valsartan, losartan, and irbesartan, was initiated due to the discovery of unexpected nitrosamine impurities like NDMA, NDEA, and NMBA, which are probable human carcinogens. These recalls have continued through 2026, leading to extensive litigation with over 1,400 lawsuits consolidated in federal multidistrict litigation as of June 2026.
Quick Answer
The Valsartan, Losartan, and Irbesartan blood pressure medications were recalled starting in 2018 due to contamination with cancer-causing nitrosamine impurities such as NDMA, NDEA, and NMBA. These impurities were found to be present at levels exceeding safe limits, prompting global regulatory actions and numerous lawsuits against manufacturers. As of June 2026, over 1,400 lawsuits are active in a federal multidistrict litigation, with bellwether trials underway to determine liability and potential settlements for individuals who developed cancer after taking the contaminated drugs.
📊Key Facts
📅Complete Timeline15 events
Initial Valsartan Recalls Begin
The FDA announces the first recalls of valsartan-containing medications due to contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
Losartan Recalls Begin
Sandoz Inc. initiates a voluntary recall of Losartan potassium hydrochlorothiazide tablets due to N-Nitrosodiethylamine (NDEA) contamination.
Aurobindo Expands Valsartan/Amlodipine/Valsartan Recall
Aurobindo Pharma USA expands its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan combination tablets due to NDEA.
Torrent Pharmaceuticals Expands Losartan Recall
Torrent Pharmaceuticals announces an expanded recall of Losartan Potassium Tablets USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP due to impurities.
First Bellwether Cases Selected in Valsartan MDL
Six bellwether lawsuits are selected in the Valsartan multidistrict litigation (MDL) to move forward, including cases involving stomach, colorectal, prostate, and liver cancer.
Deadlines Set for Second Wave of Valsartan Bellwether Trials
Deadlines are scheduled for a second wave of Valsartan bellwether trials, with the process set to run through November 2025.
First Valsartan Bellwether Trial Expected
The first bellwether trial in the federal Valsartan MDL, involving a liver cancer lawsuit, is scheduled to begin.
Motion for Class Action Settlement in Irbesartan Lawsuit
Plaintiffs file a motion for a potential class action settlement in the irbesartan portion of the Valsartan lawsuit against Aurobindo and other manufacturers.
Teva Recalls Prazosin Hydrochloride
Teva Pharmaceuticals recalls over half a million bottles of Prazosin Hydrochloride, a blood pressure and PTSD medication, due to higher levels of a cancer-linked chemical.
Teva Recalls Metoprolol Succinate
Teva Pharmaceuticals USA, Inc. initiates a recall of over 100,000 bottles of Metoprolol Succinate Extended-Release Tablets due to failed dissolution testing.
Unichem Recalls Bisoprolol Fumarate/HCTZ
Unichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to the presence of nitrosamine impurities above FDA limits.
Enalapril Maleate Tablets Recalled
J.B. Chemicals & Pharmaceuticals recalls 675 bottles of Enalapril Maleate Tablets due to a failed Organic Impurities Test.
Losartan Recalled Again for NDEA
The FDA announces another recall of Losartan over contamination with N-Nitrosodiethylamine (NDEA), a probable human carcinogen.
Chlorthalidone Tablets Recalled
Inventia Healthcare Limited recalls over 11,000 bottles of Chlorthalidone Tablets due to failed dissolution specifications, meaning the tablets may not dissolve properly.
Valsartan Lawsuits Continue in MDL
As of today, 1,413 active Valsartan lawsuits are pending in the federal multidistrict litigation, with ongoing preparations for bellwether trials.
🔍Deep Dive Analysis
The recall of valsartan, losartan, and irbesartan, a class of drugs known as angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure, began in July 2018. The initial discovery involved N-Nitrosodimethylamine (NDMA) in valsartan, a probable human carcinogen. This quickly expanded to include other ARBs and additional nitrosamine impurities such as N-Nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The root cause of the contamination was traced back to changes in the manufacturing processes of active pharmaceutical ingredients (APIs), particularly in facilities in China and India. These changes, often involving solvents and reagents, inadvertently created conditions where nitrosamines could form. The presence of these impurities was unexpected and exceeded the acceptable daily intake levels set by regulatory bodies like the U.S. Food and Drug Administration (FDA). For instance, contaminated valsartan pills were found to contain NDMA levels significantly higher than the safe daily limit of 0.096 micrograms, sometimes by over 200 times.
Key turning points in this ongoing saga include the initial widespread recalls by numerous manufacturers and distributors, the FDA's continuous updates and expansion of affected products, and the consolidation of thousands of individual lawsuits into a federal multidistrict litigation (MDL No. 2875) in the District of New Jersey. This MDL aims to streamline the legal process for plaintiffs alleging they developed various cancers, including liver, gastric, colorectal, kidney, bladder, and pancreatic cancer, due to exposure to the contaminated medications.
The consequences have been far-reaching, impacting millions of patients globally, leading to significant patient anxiety, and prompting a re-evaluation of pharmaceutical manufacturing oversight. Pharmaceutical companies involved, such as Zhejiang Huahai, Mylan Pharmaceuticals, Teva Pharmaceuticals, Solco Healthcare, and Torrent Pharmaceuticals, have faced allegations of negligence and failure to ensure product safety.
As of June 22, 2026, the situation remains active. There are 1,413 active valsartan lawsuits pending in the federal MDL, with Chief U.S. District Judge Renee M. Bumb overseeing the proceedings. Bellwether trials, designed to test legal theories and potential damages, are underway, with the first bellwether trial for a liver cancer case expected to begin in September 2025. Deadlines for a second wave of bellwether trials have also been scheduled, potentially running through November 2025. Plaintiffs are seeking compensation for medical treatments, lost wages, pain and suffering, and in some cases, punitive damages. Regulatory bodies continue to monitor and issue recalls for other blood pressure medications, such as recent recalls of Enalapril Maleate for organic impurities and Chlorthalidone for failed dissolution specifications in May and June 2026, respectively, indicating ongoing vigilance in drug safety.
What If...?
Explore alternate histories. What if The Valsartan, Losartan, and Irbesartan Blood Pressure Medication Recall made different choices?