Written By
Edited By : Kim Borwick
Medically Reviewed By : Mark C. Howell Jr., Ph.D.
This page features 22 Cited Research Articles
Fact Checked
Medically Reviewed

Board-certified physicians medically review Consumer Notice, LLC content to ensure its accuracy and quality.

Consumer Notice, LLC partners with Physicians’ Review Network Inc. to enlist specialists. PRN is a nationally recognized leader in providing independent medical reviews.

Reviewer specialties include internal medicine, gastroenterology, oncology, orthopedic surgery and psychiatry.

If you’re one of the millions of people who take the blood pressure medication valsartan, you may have been concerned by news reports that numerous batches of the drug have been tainted with potentially cancer-causing chemicals.

The ever-expanding list of products affected by the recalls has created confusion for many consumers who originally thought their valsartan was safe only to see it recalled later. The massive recall has also led to shortages of the important blood pressure drug and substantial price increases of non-recalled valsartan.

Recalls

In July 2018, the U.S. Food and Drug Administration announced that three companies had voluntarily recalled several lots of valsartan, which is the generic version of Diovan, because they were contaminated with N-nitrosodimethylamine, or NDMA.

The chemical is known to cause cancerous tumors of the liver, kidney and respiratory tract in animals, and it’s believed to cause cancer in humans.

Exactly how the cancer-causing toxin ended up in the pills isn’t entirely clear. But a preliminary investigation by the FDA suggests that the NDMA was a byproduct of changes in the way Chinese drug companies manufactured valsartan. Manufacturers in China and India produce more than two-thirds of the active ingredients in pharmaceuticals, according to Reuters.

Our investigation into ZHP’s process identified that a change made to the manufacturing process likely led to this impurity, and that the impurity went undetected by global regulators, including the FDA, for a period of time.
— Statement from former FDA Commissioner Scott Gottlieb and Janet Woodcock, director of the Center for Drug Evaluation and Research

While the manufacturing changes were first implemented around 2012, regulators didn’t discover problems until six years later.

In May 2018, the European Medicines Agency, the FDA’s European counterpart, announced it was reviewing valsartan products supplied by Zhejiang Huahai Pharmaceuticals after the Chinese company revealed it had detected NDMA in some of its valsartan supply.

Two months later, 22 countries in Europe and Asia began recalling valsartan products, and the United States quickly followed.

“Our investigation into ZHP’s process identified that a change made to the manufacturing process likely led to this impurity, and that the impurity went undetected by global regulators, including the FDA, for a period of time,” former FDA Commissioner Scott Gottlieb and Janet Woodcock, director of the Center for Drug Evaluation and Research, said in a statement.

three icons representing filing a lawsuit
Were you diagnosed with cancer after taking valsartan?
Get your free case review today.

Affected Drugs

The initial recall involved five valsartan products sold by three companies, but the recall eventually expanded to include more than a dozen other companies and other similar blood pressure medications, including losartan and irbesartan.

These medications belong to a class of drugs known as angiotensin II receptor blockers, or ARBs. ARBs work to lower blood pressure by relaxing blood vessels, thereby making it easier for the heart to pump. They do this by blocking a protein in your body called angiotensin II, which normally causes blood vessels to narrow.

Lowering blood pressure reduces the risk of strokes and heart attacks. The FDA approved valsartan not only to treat high blood pressure, but also to treat heart failure.

CONSUMER RESOURCE:
You can find the manufacturer of your medication by looking at the drug label on your pill bottle or by checking the medication insert and comparing it to the FDA’s valsartan recall list.

In addition to NDMA, other “probable” carcinogens, including N-nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), have been found in some of the recalled products.

The valsartan products under recall include various tablet strengths and formulations as well as blood pressure drugs that combine valsartan with other ingredients, such as amlodipine and hydrochlorothiazide (HCTZ).

Companies that manufactured or distributed recalled valsartan products include:

  • American Health Packaging (Aurobindo)
  • A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco)
  • Aurobindo Pharma USA Inc.
  • Aurobindo Pharma USA Inc. (Acetris)
  • AvKARE (Hetero/Camber)
  • AvKARE (Teva/Actavis)
  • Bryant Ranch Prepack Inc. (Teva/Actavis)
  • H J Harkins Company Inc., doing business as Pharma Pac (Prinston/Solco)
  • Hetero Labs, Inc., labeled as Camber Pharmaceuticals
  • Mylan Pharmaceuticals
  • Northwind Pharmaceuticals (Teva/Actavis)
  • NuCare Pharmaceuticals Inc. (Prinston/Solco)
  • Preferred Pharmaceuticals Inc. (Hetero/Camber)
  • Prinston Pharmaceutical Inc., labeled as Solco Healthcare LLC.
  • RemedyRepack Inc. (Hetero/Camber)
  • RemedyRepack Inc. (Prinston/Solco)
  • RemedyRepack Inc. (Torrent)
  • Rising Pharmaceuticals Inc., labeled as Acetris Health, LLC
  • Teva Pharmaceuticals, labeled as Major Pharmaceuticals
  • Teva Pharmaceuticals USA Inc.
  • Teva Pharmaceuticals USA, labeled as Actavis
  • Torrent Pharmaceuticals Limited

Losartan recalls announced by the FDA include more than 200 drug lots sold by multiple companies, including: AvKare (repackager for Torrent); Camber Pharmaceuticals Inc.; Legacy Pharmaceutical Packaging LLC (Hetero Camber); Macleods Pharmaceutical Ltd.; Preferred Pharmaceuticals Inc. (Torrent Pharmaceuticals Limited); Sandoz Inc. and Torrent Pharmaceuticals Ltd.

Recalled irbesartan products include about 50 lots sold by: Prinston Pharmaceutical Inc. doing business as Solco Healthcare LLC; ScieGen Pharmaceuticals labeled as GSMS Incorporated; and ScieGen Pharmaceuticals labeled as Westminster Pharmaceuticals.

It’s important to talk to your doctor or pharmacist if your medication has been recalled.

Drug Shortages and Price Hikes

The widespread recalls of valsartan and other ARBs have had unintended consequences.

As the drug recalls expanded, shortages of the drug emerged, and some companies seized on the opportunity to dramatically raise their prices.

DID YOU KNOW?
In March 2019, the FDA approved a new generic of valsartan to help relieve the shortage of the medicine.

Alembic Pharmaceuticals, for instance, more than tripled the price of more than a dozen of its valsartan products in 2018 after competitors withdrew tainted versions from the market, according to USA Today. When batches of irbesartan were later recalled, the company hiked the price of that drug, too.

In March 2019, the FDA approved a new generic of valsartan manufactured by Alkem Laboratories Ltd. to help address the valsartan and losartan shortages. The watchdog agency said it carefully evaluated Alkem’s manufacturing processes to ensure the new drug does not contain NDMA or NDEA.

Infographic about Alembic Pharmaceuticals stat, Alembic pharmaceuticals tripled the price of valsartan products in 2018

Health Problems from Contamination

In most cases, patients who’ve taken tainted valsartan will not experience any side effects. In rare cases, patients may develop cancer.

Animal studies have linked excessive NDMA ingestion to liver disease, liver cancer and other diseases. According to the Centers for Disease Control and Prevention’s Agency for Toxic Substance and Disease Registry, it is “reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”

Because of these risks, the federal government limits the amount of NDMA, NDEA and NMBA that is considered “acceptable” in valsartan and other similar blood pressure medications. The amounts of NDMA, NDEA and NMBA in the recalled drugs exceeded those levels.

According to the FDA, consumers might have first been exposed to these tainted medications as far back as 2014. FDA scientists estimate that if 8,000 people took a 320 mg dose of tainted valsartan every day for four years, “there may be one additional case of cancer over the lifetimes of these 8,000 people.”

General Side Effect Information

People may have reactions to valsartan that has not been contaminated, though most people tolerate the medicine well. Side effects such as dizziness and lightheadedness will usually go away as your body adjusts to the medication.

Other possible side effects may include headache, rash, coughing, tiredness, nausea, diarrhea, abdominal pain, back pain and blurred vision. Call your doctor or seek medical attention if you experience fainting, a slow or irregular heartbeat, muscle weakness or signs of an allergic reaction.

Pregnant women should not take valsartan because it may cause injury or death to the developing fetus during the second and third trimester.

What Patients Need to Know

If you discover that your valsartan has been recalled, don’t stop taking it until you speak with your doctor or pharmacist. Suddenly stopping any blood pressure medication may cause a dangerous spike in blood pressure, which can lead to health complications such as a heart attack, stroke or kidney damage.

The FDA also wants patients to know:

  • Not all valsartan meds have been recalled.
  • You can check the FDA’s lists of valsartan recalls, losartan recalls and irbesartan recalls to see if your medication has been recalled or contact your pharmacist.
  • If you see your medication on any of the recall lists above, contact your doctor or pharmacist to talk about treatment options.

If you’ve been injured by tainted valsartan, you may be entitled to compensation. Lawyers are filing valsartan lawsuits on behalf of consumers who developed cancer or serious kidney or liver injuries after taking tainted valsartan.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: October 24, 2023

22 Cited Research Articles

Consumernotice.org adheres to the highest ethical standards for content production and references only credible sources of information, including government reports, interviews with experts, highly regarded nonprofit organizations, peer-reviewed journals, court records and academic organizations. You can learn more about our dedication to relevance, accuracy and transparency by reading our editorial policy.

  1. U.S. Food and Drug Administration. (2019, March 12). FDA approves a new generic valsartan. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-generic-valsartan
  2. U.S. Food and Drug Administration. (2019, March 1). FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-arb-drug-products-reports-finding-new-nitrosamine
  3. U.S. Food and Drug Administration. (2019, March 1). FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan
  4. U.S. Food and Drug Administration. (2019, March 1). Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and
  5. Scutti, S. (2019, February 22). FDA official says ongoing blood pressure drug investigation will probably uncover more tainted pills. Retrieved from https://www.cnn.com/2019/02/22/health/fda-recall-valsartan-arbs/index.html
  6. Neal, D. (2019, January 30). Here’s the latest from the FDA on blood pressure meds with a cancer-causing element. Retrieved from https://www.miamiherald.com/news/health-care/article225160165.html?fbclid=IwAR04ODQg0EPXvZgCGFPJJmJo9WXP64l8PlWrKJBn16RWy5lRF_bGyzrPPt4
  7. Alltucker, K. (2019, January 30). A ‘one-off opportunity;’ Drug company hikes price of blood pressure drugs after competitors’ drugs recalled. Retrieved from https://www.usatoday.com/story/news/health/2019/01/30/blood-pressure-medicine-recall-alembic-teva-prinston-pharmaceuticals-price-hikes/2709633002/
  8. U.S. National Library of Medicine. (2019, January 28). Valsartan. Retrieved from https://medlineplus.gov/druginfo/meds/a697015.html
  9. U.S. Food and Drug Administration. (2019, January 25). Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address to root causes of the safety issues. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-statement-fdas-ongoing-investigation-valsartan-and-arb-class-impurities-and-agencys-steps
  10. The Daily Caller. (2019, January 18). Drug Companies Used Shortages, Recalls to Hike Prices as Much as 1,137 Percent, Report Finds. Retrieved from https://dailycaller.com/2019/01/18/drug-companies-price-increases/
  11. May, A. (2019, January 2). More blood pressure medication recalled: Company recalls 80 lots of valsartan over cancer concerns. Retrieved from https://www.usatoday.com/story/money/business/2019/01/02/blood-pressure-drug-recall-valsartan-pulled-over-cancer-worry/2461944002/
  12. Diagnostic and Interventional Cardiology. (2018, December 11). Nationwide Recall of Valsartan Blood Pressure Medication Expanded. Retrieved from https://www.dicardiology.com/content/nationwide-recall-valsartan-blood-pressure-medication-expanded
  13. Harney, A. & Hirschler, B. (2018, August 22). Toxin at heart of drug recall shows holes in medical safety net. Retrieved from https://www.reuters.com/article/us-health-pharmaceuticals-china-insight/toxin-at-heart-of-drug-recall-shows-holes-in-medical-safety-net-idUSKCN1L71D8
  14. CVS caremark. (2018, July 13). Drug Safety Alerts: Valsartan Tablets Voluntary recall. Retrieved from https://www.caremark.com/wps/portal/FOR_HEALTH_PROS_DRUG_SAFETY_ALERTS?cms=CMS-PWCM-1107679
  15. U.S. Food and Drug Administration. (2018, July 13). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity
  16. Weber, C. (2018, June 17). How the Renin-Angiotensin (RAA) System Works to Regulate Blood Pressure. Retrieved from https://www.verywellhealth.com/what-is-the-renin-angiotensin-system-1763941
  17. European Medicines Agency. (2018, May 7). EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity: some valsartan medicines being recalled across the EU. Retrieved from https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity-some
  18. ClinCalc.com. (2017, February 11). ClinCalc DrugStats Database. Retrieved from https://clincalc.com/DrugStats/
  19. Andresen, B., Anderson, S.D., Yeon, J.K. & Mireles, R. (2017). Valsartan. Retrieved from https://www.sciencedirect.com/science/article/pii/B9780128012383641363
  20. Tazkarji, B., Ganeshamoorthy, A. & Auten, B. (2015, February 1). Angiotensin-Converting Enzyme Inhibitors vs. Angiotensin Receptor Blockers. Retrieved from https://www.aafp.org/afp/2015/0201/p193.html
  21. Li, E.C., Heran, B.S. & Wright, J.M. (2014, August 22). Angiotensin converting enzyme (ACE) inhibitors versus angiotensin receptor blockers for primary hypertension. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25148386
  22. WebMD. (n.d.). Valsartan. Retrieved from https://www.webmd.com/drugs/2/drug-849/valsartan-oral/details