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.

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.

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.

Learn more about the cancer risk posed by the impurities here>>>

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.

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.

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.