Blood pressure medication losartan recall

Certain batches of generic medications containing losartan were voluntarily recalled in 2019 (FDA, 2019-d). Some batches of this medication were also recalled in 2018 (FDA, 2018-b). 

Losartan belongs to a class of medications called angiotensin II receptor blockers, or ARBs. These drugs are considered the first-line treatment for high blood pressure (hypertension), but they can be used to treat other conditions as well. Losartan is also approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of stroke and kidney problems in people with diabetes (diabetic nephropathy) (DailyMed, 2020). Losartan is available as a generic drug but is also sold under the brand name Cozaar.

Losartan may also be used off-label after a heart attack to help people with heart failure and to treat kidney disease in people who don’t have diabetes. It may also be used to help prevent a life-threatening heart condition common in people who have Marfan’s syndrome, a rare, inherited connective tissue disorder (UpToDate, n.d.). 

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In 2018 and 2019, certain batches of losartan produced in its generic form by Torrent Pharmaceuticals, Teva Pharmaceuticals, Macleods Pharmaceuticals, and Camber Pharmaceuticals were recalled by the FDA (FDA, 2019-a; FDA, 2019-e; FDA, 2019-b; FDA, 2019-c). The brand name medication, Cozaar, which is manufactured by Merck, was not involved in the recall.

The recall included both losartan potassium tablets USP and combination tablets containing both losartan and hydrochlorothiazide. The recall did not include all batches (also called lots) of these medications, so you need to check your prescription label to see if yours is affected. To check your medication, compare the lot number and expiration date from the label against the list of lots of losartan potassium tablets recalled (FDA, 2019-f).

The recall was initiated because these batches of the medications contained more than the acceptable amount of a compound called N-Methylnitrosobutyric acid, or NMBA. The FDA allows only a certain amount of NMBA in products, but some lots of these medications contained more than the permitted amount. It’s important to know that no adverse events have been reported by people taking the recalled medications (FDA, 2019-d).

If you are concerned that your medication is part of the affected lot, do not stop taking your medication before consulting with your healthcare provider. It can be more dangerous to abruptly stop taking your medication than to continue to take losartan products affected by this recall. Your healthcare provider may offer you a new prescription or alternative medication to ensure that your blood pressure remains stable (FDA, 2019-d).

The standard starting dose for adults taking losartan is 50 mg, taken once a day in the form of a tablet but dosages vary based on the indication and your personal treatment regimen established by your healthcare provider. If you are receiving treatment for high blood pressure and left ventricular atrophy, you may be prescribed losartan in combination with a diuretic such as hydrochlorothiazide to reduce how hard your heart has to work to pump (FDA, 2018-a).

Some individuals with specific health considerations may be started on a lower dose of losartan (25 mg), taken once daily. A lower dose is more commonly prescribed in individuals with underlying liver conditions or those with volume depletion (low fluid levels in the body), which can be caused by diuretic medications (FDA, 2018-a).

For some people, 50 mg of losartan may not be enough to adequately lower high blood pressure. These individuals may have their dosage increased from 50 mg to 100 mg, taken once daily (FDA, 2018-a).

The most common possible side effects of losartan include dizziness, stuffy nose, back pain, chest pain, diarrhea, high potassium levels, low blood pressure, low blood sugar, and tiredness (FDA, 2018-a). In rare cases, Cozaar may cause a severe allergic reaction, which can include hives, itching, rash, or trouble breathing. If you experience any of these symptoms, seek medical attention immediately. 

Since losartan is a medication used to lower blood pressure, sometimes it can lower blood pressure too much, which can cause dizziness or even fainting. In certain cases, it can reduce blood flow to the kidneys, causing kidney failure. In addition, it can cause high blood potassium (hyperkalemia) (UpToDate, n.d.). Hyperkalemia can be mild or serious, potentially causing heart problems such as arrhythmias (irregular heartbeat) that can be life-threatening (Simon, 2020). 

Since high blood levels of potassium can be dangerous, you may need to avoid high-potassium foods when taking ARBs such as generic Cozaar. Past research suggests that high dietary potassium may be safe for people with proper kidney function since the kidneys get rid of any excess potassium in the body (Malta, 2016; National Kidney Foundation, 2020). But that also means those taking ARBs such as losartan who already have kidney problems such as chronic kidney disease (CKD) may need to limit high-potassium foods such as potatoes, tomatoes, oranges, and bananas (Han, 2013). 

Salt substitutes that use potassium chloride and potassium supplements should also be avoided by anyone taking Cozaar. These sources of potassium have not been proven safe like dietary potassium and should be avoided even if you have normal kidney function. Your serum potassium levels may be used to determine how much high-potassium foods should be limited. 

Losartan may also cause serious adverse effects when combined with certain medications. Toxicity may result from combining losartan and lithium. Taking NSAIDs (over-the-counter pain killers like ibuprofen and naproxen) while you’re on losartan may limit its effect on your blood pressure. Drug interactions such as dangerously low blood pressure may also occur if this prescription medicine is mixed with ACE inhibitors or aliskiren, two other types of medications used to lower blood pressure (DailyMed, 2020).

People with liver problems should be cautioned when taking losartan. The liver is responsible for clearing this drug from the bloodstream, so if the liver isn’t working properly, people can experience increased drug levels, which can lead to serious drops in blood pressure. 

Tell your healthcare provider if you have any history of kidney problems as losartan can worsen kidney function, particularly in patients with a condition called renal artery stenosis (where the blood vessel that supplies the kidneys doesn’t supply enough blood) (DailyMed, 2020).

You should stop taking losartan if you become pregnant as the drug may cause fetal injury or even fetal death if taken during the final six months (second and third trimesters) of pregnancy. You should not breastfeed when taking losartan as the medication may pass into the breast milk (FDA, 2018-a). 

Tell your healthcare provider or pharmacist about any other drugs or supplements you’re taking before starting this medication.

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Current version

September 10, 2020

Written by

Linnea Zielinski

Fact checked by

Yael Cooperman, MD

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About the medical reviewer

Yael Cooperman, MD, Ro

Yael Cooperman is a physician and works as a Senior Manager, Medical Content & Education at Ro.