Understanding the Losartan Recalls: Why Was Losartan Taken Off the Market?

October 11, 2025 •

3 min read

Between 2018 and 2021, a series of voluntary recalls for certain batches of losartan led many to believe it was completely removed from the market. The widespread concern prompted by these recalls has a clear explanation, clarifying why losartan was taken off the market in specific instances, but remains available today.

Quick Summary

Specific lots of the blood pressure medication losartan were voluntarily recalled by various manufacturers between 2018 and 2021 due to the detection of probable human carcinogen impurities. This was not a permanent removal, and unaffected versions of the drug remain on the market.

Key Points

Temporary, not Permanent: Specific lots of losartan were recalled, the drug itself was not permanently removed.
Cause for Recall: The recalls were prompted by the discovery of NMBA and NDEA, probable human carcinogens, as a result of manufacturing issues.
FDA Investigation: The recalls were part of a broader FDA investigation into ARB blood pressure medications.
Patient Safety Advice: The FDA advised against abruptly stopping recalled medication, prioritizing continued treatment.
Current Availability: Corrective actions were taken, and unaffected losartan products remain safe and available.
Manufacturing Fault: The contamination was traced to the manufacturing process of the active pharmaceutical ingredient, often from overseas suppliers.

The Losartan Recalls and Public Concern

Losartan, a commonly prescribed angiotensin II receptor blocker (ARB) used to treat high blood pressure, was subject to voluntary recalls by multiple pharmaceutical companies between 2018 and 2021 in coordination with the FDA. These actions led to the misconception that the drug was permanently removed, but only specific batches containing impurities were affected.

Identification of Nitrosamine Impurities

The recalls were prompted by the discovery of unacceptable levels of nitrosamine impurities in the active pharmaceutical ingredient (API) of some losartan products during routine testing. The primary impurities identified were:

N-Methylnitrosobutyric acid (NMBA): Classified as a probable human carcinogen, and found in products from different manufacturers.
N-Nitrosodiethylamine (NDEA): Also found in certain losartan and losartan/HCTZ tablets.

It is worth noting that while other ARBs were recalled for different nitrosamines like NDMA, losartan recalls primarily involved NMBA and NDEA. The source of these contaminants was traced to manufacturing issues at API suppliers, mainly in India and China.

FDA's Investigation and Actions

These losartan recalls were part of a larger FDA investigation into all ARB medications, which began in 2018 following the initial discovery of NDMA in valsartan. The FDA worked with manufacturers to find the cause of contamination, set safe limits for impurities, and protect patients.

The FDA's actions led to numerous recalls across the industry. Despite the concerns, the FDA indicated that the cancer risk from the recalled drugs was low for most individuals and mainly associated with long-term, high-dose use. Patients were advised against stopping their medication suddenly without consulting a healthcare professional.

Comparison of Losartan Recalls

Multiple manufacturers were involved in the losartan recalls between 2018 and 2021, driven by the detection of different impurities. The table below summarizes some significant recall events.


Manufacturer	Product(s)	Contaminant Detected	Recall Year(s)	Status	Citations
Torrent Pharmaceuticals	Losartan Potassium & Losartan/HCTZ	NDEA & NMBA	2018-2019	Recalls Completed
Sandoz Inc.	Losartan/HCTZ	NDEA	2018	Recalls Completed
Camber Pharmaceuticals	Losartan Potassium	NMBA	2019	Recalls Completed
Teva Pharmaceuticals	Losartan Potassium	NMBA	2019	Recalls Completed
Macleods Pharmaceuticals	Losartan Potassium & Losartan/HCTZ	NDEA & NMBA	2019	Recalls Completed
Jubilant Cadista	Losartan Potassium & Losartan/HCTZ	Azido	2021	Market Withdrawal

The Resumption of Safe Losartan Production

Following the recalls, manufacturers improved their production to remove the nitrosamine contaminants. The FDA's oversight was crucial in ensuring that all losartan met safety standards. The recalls were isolated incidents caused by specific manufacturing issues, not a problem with the drug itself.

Losartan is currently widely available and safely prescribed for high blood pressure and other conditions. Patients can be assured that their medication is from manufacturers who have resolved the contamination problems. Those affected by recalls could switch to uncontaminated batches or alternative medications with their healthcare provider's guidance.

What to Do If You Were Affected

The FDA advised patients not to stop taking recalled medication abruptly due to the greater risk of complications like stroke or heart attack compared to the low risk from the impurities. Patients should contact their pharmacist or doctor to determine if their medication was recalled and to arrange for a replacement or alternative treatment.

Conclusion

Losartan was not permanently removed from the market. Certain batches were temporarily recalled between 2018 and 2021 due to the presence of probable human carcinogen impurities like NMBA and NDEA, linked to manufacturing issues. Manufacturers, under FDA oversight, corrected these problems, ensuring the safety of current losartan products. This event underscores the critical need for quality control in drug manufacturing and the FDA's role in safeguarding drug safety. Patients with concerns should always consult their healthcare providers.

Visit the FDA website for more information on the losartan recall history.

Frequently Asked Questions

Losartan was recalled because certain lots were found to contain unacceptable levels of nitrosamine impurities, specifically N-Methylnitrosobutyric acid (NMBA) and N-Nitrosodiethylamine (NDEA), classified as probable human carcinogens.

Yes, losartan is still on the market. Only specific batches and lots were recalled by manufacturers, and subsequent production has corrected the issues that led to the contamination.

The recalls were specific to certain manufacturers and particular lots of the medication, not the entire losartan market. Many brands and generic versions were affected, including products from Torrent, Teva, and Camber.

The nitrosamine impurities found in the recalled lots are probable human carcinogens, meaning they could increase the risk of cancer over long-term exposure. The FDA noted that the risk was likely low, and that discontinuing medication abruptly poses a greater immediate health risk.

The contamination was linked to the manufacturing process of the active pharmaceutical ingredient (API), with suppliers primarily based in India and China. The impurities were formed as a byproduct during production.

Do not stop taking the medication immediately if you are concerned. Contact your pharmacist or healthcare provider to determine if your specific prescription was part of a recall and to discuss alternative treatment options.

You can check the manufacturer, lot number, and expiration date on your prescription bottle and compare it to the lists published by the FDA on their website. Your pharmacy can also help you determine if your batch was affected.