U. S. Food and Drug Administration

Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards.

Losartan Recall

Between July 2018 and September 2019, the U.S. Food and Drug Administration (FDA) announced the recall of hundreds of lots of blood pressure drugs. The recall was prompted by the discovery of cancer-causing impurities in the medications.

In July 2018, valsartan was the first blood pressure drug recalled. Valsartan is a similar blood pressure medication to losartan. A recall on losartan medications soon followed. Manufacturers recalled hundreds of lots of generic losartan over the course of the next year.

What Is Losartan?

Losartan is an angiotensin II receptor blocker (ARB). An ARB is a type of blood pressure drug. It works by keeping a person’s blood vessels unconstricted, thereby preventing pressure from building.

Losartan is sold under the brand name Cozaar. It can also be found in generic forms.

Uses
Losartan is approved to treat hypertension or high blood pressure. It has also been used to reduce the risk of stroke in patients with high blood pressure or left ventricular hypertrophy. Lastly, losartan is approved to treat kidney disease in certain patients with type 2 diabetes.

Common Side Effects

• Dizziness
• Upper Respiratory Infections
• Nasal Congestion
• Back Pain
• Low Blood Pressure

Why Was Losartan Recalled?

The FDA announced a recall of losartan because of contamination. During its investigation, the agency identified three probable human carcinogens in certain ARBs.

A carcinogen is a substance capable of causing cancer in a living thing.

The three impurities found were N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric Acid (NMBA). Losartan was not affected by NDMA. However, it was the only ARB recalled because of NMBA.

Evidence shows that all three compounds promote tumor growth in animals. However, the compounds have not been studied definitively in humans.

Carcinogens in Losartan

N-Nitrosodiethylamine (NDEA)

NDEA is a synthetic oil that is sometimes added to gasoline and lubricants as a stabilizer. It is known as a probable human carcinogen.

N-Nitroso-N-methyl-4-aminobutyric Acid (NMBA)

NMBA is a yellow oil found in various forms of tobacco. It is a potential human carcinogen.

How Did the Contamination Happen?

The contamination of blood pressure medications was a result of a chemical reaction during the manufacturing process.

During its investigation, the FDA found that the contamination started during the production of the drug’s active pharmaceutical ingredient (API). For example, losartan is the API found in Cozaar and other generic versions of the brand name.

API suppliers in India and China inadvertently produced contaminated ingredients. The companies then sold these contaminated products to drug companies. These companies unknowingly used contaminated API in their medications and sold the finished drugs to consumers.

What Losartan Has Been Recalled?

The FDA has compiled a list of all the contaminated blood pressure medications. We have collected all the losartan recall information in the expandable table below.

If you’re concerned you may be taking recalled losartan, compare the information on your prescription drug label with the information in the table.

Losartan Recall List

Expand to See a Full List of Recalled Losartan

Current as of January 21, 2020

Is All Losartan Recalled?

No — only contaminated losartan has been recalled. To find safe losartan, visit the FDA’s website to view a list of products still on the market.

What Other Blood Pressure Medications Are Being Recalled?

The FDA named three ARBs in the agency’s recall updates: valsartan, losartan, and irbesartan. Hundreds of lots of these medications have been recalled.

Apart from recalls, the manufacturers of these drugs are being sued by consumers. In fact, many valsartan lawsuits are now being consolidated into multidistrict litigation. Visit our valsartan lawsuit page to learn more about litigation surrounding the blood pressure drug.

The number of new ARBs recalls declined at the end of 2019. However, around this time, another drug was found contaminated with NDMA. The heartburn drug Zantac and several generic versions of the drug were recalled due to contamination in September 2019.

What Should I Do if my Losartan Prescription Was Recalled?

1. Do not stop taking your recalled losartan medication. High blood pressure can be life-threatening. Do not discontinue your medication without consulting a healthcare professional. Doing so can lead to serious health risks.
2. Talk to your doctor. Your doctor can explain the potential health risks posed by recalled losartan. Your doctor can also prescribe a safe losartan replacement.

Consider contacting your local pharmacist or the drug manufacturer. They can provide you with information about the proper disposal of the recalled drug. Additionally, they may be able to provide valuable information about refund opportunities.

Losartan Recall FAQs

Is Losartan Safe?

Yes — the safety of the drug itself is not the issue in the recall of losartan. The issue lies solely with the contamination.

In general, losartan is a safe drug. Contaminated losartan, however, may pose serious health risks. Contact your doctor if you are taking recalled losartan to get a safer alternative treatment.

Does Losartan Contain NDMA?

No — NDMA was not found in losartan medications. Losartan medications were recalled due to the presence of NDEA and NMBA.

Authored by Katy Moncivais, Ph.D. Medical Editor

Katy Moncivais holds a Ph.D. in Biomedical Engineering from The University of Texas at Austin. She’s an experienced Regenerative Medicine Consultant with a demonstrated history of working in the hospital & healthcare industry. Skilled in adult stem cells, medical devices, biomechanics, bacterial and mammalian cell culture, and regenerative medicine, she provides guidance on an array of topics affecting consumers. In her role at ConsumerSafety.org, Dr. Moncivais works alongside the writing and research staff to help deliver fact-based news stories to consumers. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. In addition, Dr. Moncivais reviews portions of medically driven content to ensure scientific accuracy.

Related Pages

• What is Valsartan?
• Valsartan Recall
• Losartan Recall
• Valsartan Cancer Risk
• Valsartan Lawsuit
• Free Case Review

• 1 BOC Sciences. N-NITROSO-N-METHYL-4-AMINOBUTYRIC ACID – CAS 61445-55-4. N.D.
• 2 Office of Solid Waste and Emergency Response. Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA). U.S. Environmental Protection Agency. EPA 505-F-14-005. January 2014.
• 3 U.S. Food and Drug Administration. Cozaar (losartan) Highlights of Prescribing Information. October 2018.
• 4 U.S. Food and Drug Administration. FDA’s Assessment of Currently Marketed ARB Drug Products. Updated April 4, 2019.
• 5 U.S. Food and Drug Administration. FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). Updated November 7, 2019.
• 6 U.S. Food and Drug Administration. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. Updated September 23, 2019.
• 7 U.S. National Library of Medicine. N-Nitrosodiethylamine. PubChem.
• 8 U.S. National Library of Medicine. N-Methyl-N-(3-carboxypropyl)nitrosamine. PubChem.

Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

What are valsartan, losartan, and irbesartan?

Valsartan, losartan, irbesartan and other “-sartan” drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure.

Why are some valsartan, losartan, and irbesartan medicines being recalled?

Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards.

• Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens (a substance that could cause cancer), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen.
• Nitrosamines are known environmental contaminants and found in water and foods, including meats, dairy products and vegetables.
• The presence of these nitrosamine impurities in ARB medicines was unexpected. Our ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.

Which ARB medications are being recalled?

Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled.

Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. FDA has posted a list of currently available ARBs and the status of our assessment of those medications.

Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled.

Some manufacturers are recalling some medications containing amlodipine in combination with valsartan or losartan, and some medications containing hydrochlorothiazide HCTZ in combination with valsartan or losartan are also being recalled.

To find out if your medication has been recalled, you need the following information:

• Manufacturer or labeler name
• National Drug Code (NDC)
• Lot number
• Active ingredient(s)

Why didn’t FDA identify the risk of these impurities earlier?

We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities.

Manufacturers are required to test for impurities that may be introduced or developed during their manufacturing processes.

We review that information in drug applications, including requests to change the manufacturing process.

We employ organic chemists to review applications and referenced information to look for steps – and manufacturing changes – where these risks could be introduced.

We also inspect manufacturing facilities around the world, and in routine current good manufacturing practices inspections we can review a manufacturer’s records regarding impurity testing.

However, the review of records depends on manufacturers conducting appropriate tests that are capable of detecting the impurity.

Tests are selected based on assessments of what impurities may develop based on the manufacturing process.

In other words, it needs to be recognized that there is a risk of an impurity occurring to know that it should be tested for.

Before we undertook this analysis, neither regulators nor industry fully understood how the nitrosamines could form during the manufacturing process.

Where do I find the manufacturer or repackager name and National Drug Code (NDC) of my medication?

Following is an example of an ARB medication label to help you identify the information on your medication:

Note the manufacturer may be different from the distributor or labeler of your medication. Learn more about the NDC.

Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.

Where do I find the lot number of my medication?

If the lot number is on the medication bottle, it is usually imprinted on the label and is normally found next to the expiration date. It will also be printed on the back of a blister pack.

Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.

What is the risk to patients who have taken the affected product?

NDMA was the first impurity discovered, and FDA pharmacologists, toxicologists and chemists have taken measures to assess its risk.

Our scientists estimate that if 8,000 people took the highest daily valsartan dose (320 mg) that contained NDMA for four years (the amount of time we believed the affected products had been on the U.S. market), there may be one additional case of cancer beyond the average cancer rate among Americans.

Most patients who were exposed to the impurity through the use of affected valsartan received less exposure than in the scenario described above.

Since there are many manufacturers of valsartan and sources can vary whenever a patient refills a prescription, it is very likely that a patient using valsartan for four years would not have always received one of the relatively few affected medicines that contained these impurities.

We are still seeking to similarly quantify the risk to patients from NDEA and will communicate our findings as soon as possible.

Should I continue taking my medication even if it has been recalled?

Yes. Because ARBs treat serious medical conditions, continue taking your current medicine until a doctor or pharmacist gives you a replacement or a different treatment option.

Remember, not all ARBs are being recalled, and not all lots of valsartan, irbesartan, and losartan are affected and being recalled.

If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled.

• If you have medicine included in a recall, contact your pharmacist. The pharmacist may be able to provide you with an unaffected ARB made by another company.
• If the pharmacist cannot provide this, contact your doctor to discuss other treatment options.

Report any unexpected side effects with ARB-containing medicines, to FDA’s MedWatch program to help the agency better understand the scope of the problem:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

What is FDA doing to ensure all affected products are quickly removed from the market?

We are working with manufacturers to recall medicines with nitrosamine impurities above the interim acceptable intake levels that present an unnecessary risk to patients.

Lists of ARB medicines affected by the recall are available on FDA’s website for healthcare professionals and patients to monitor.

We will update our website if any other medicines are recalled due to these impurities.

We are also working with makers of API to ensure they remediate their manufacturing processes and their API does not contain these impurities.

What do I do with my unused medication?

Return it to your pharmacist when you get your new medication.

What should I know as a health care professional?

FDA has determined the recalled ARBs pose an unnecessary risk to patients.

FDA recommends that pharmacists provide a replacement medicine not affected by the recall or prescribers consider other available treatment options for their patient’s medical condition.

A list of ARB medications affected by the recall are available on FDA’s website for healthcare professionals and patients to monitor. FDA has also posted a list of ARBs that are currently available, along with information regarding the status of FDA’s assessment for those medications.

FDA suggests health care professionals check the lists regularly for updates.

Samples can also be affected and part of the recall. Be certain to check samples to ensure affected products are not given to patients.

• If you have medication samples from these companies, quarantine the products, and do not provide them to patients.

Report any adverse reactions with ARB-containing products, to FDA’s MedWatch program to help the agency better understand the scope of the problem:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

How do I find out more information?

FDA’s website contains the most current information about the affected products.

Please send us questions or comments by email to [email protected] or by phone to 855-543-3784 .

Patients and health care professionals should report any unexpected adverse event with ARB-containing products to the FDA’s MedWatch program to help the agency better understand the scope of the problem:

• Complete and submit the report online at www.FDA.gov/medwatch/report.htm or
• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178 .

Resources for You

• Search ARB Recalls List
• FDA Updates on ARB Recalls
• Nitrosamine Impurities in Medications