Has losartan (angiotensin II receptor antagonist) been recently recalled?

Losartan Recall Status

Losartan was recalled in 2018-2019 due to the presence of potentially carcinogenic nitrosamine impurities in selected lots, but this is not a recent recall. 1

Background on the Recall

• The losartan recall began in July 2018 when certain lots were found to contain nitrosamine impurities (N-nitrosodimethylamine [NDMA], N-nitrosodiethylamine [NDEA], and N-nitroso-N-methyl-4-aminobutyric acid [NMBA]) at levels exceeding acceptable limits 1, 2
• More than two dozen specific angiotensin receptor blocker (ARB) products, including losartan, were voluntarily recalled by pharmaceutical companies 1
• The impurities were thought to be formed due to changes in the manufacturing processes of these medications 3
• The FDA categorized marketed ARB products in April 2019 regarding nitrosamine impurities as: (1) not present, (2) to be determined with no prior lots removed from the market, or (3) to be determined with prior lots having been removed 1

Scope and Impact of the Recall

• Losartan was the ninth most prescribed drug in the United States in 2016, making this recall significant 1
• The FDA database showed that more than 1400 product lots were recalled from the market due to nitrosamine impurities exceeding the acceptable intake limit of 26.5 ng/day 2
• Besides losartan, other ARBs affected included valsartan and irbesartan 3
• These nitrosamine compounds are classified as carcinogens and are harmful if consumed beyond certain acceptable daily limits 3

Current Status

• The recalls were primarily in 2018-2019, not recently 1, 2
• The FDA has since issued guidance (September 2020) for the pharmaceutical industry regarding the control of nitrosamines in drug products 2
• Periodic quality assessment of the manufacturing process and drugs is now emphasized to ensure safe, effective, and high-quality medications 3

Clinical Implications

• Losartan remains an important medication for hypertension and heart failure management 4
• The American College of Cardiology and American Heart Association guidelines continue to recommend losartan as an effective angiotensin receptor blocker 5, 4
• For heart failure patients with reduced ejection fraction, the target dose of losartan is 100 mg once daily 4
• Higher doses of losartan (100-150 mg) have shown better cardiovascular outcomes in clinical trials compared to lower doses 4

Key Takeaway

• While there was a significant recall of losartan products in 2018-2019, this is not a recent event, and losartan continues to be prescribed and used effectively for hypertension and heart failure management 1, 4