Losartan Voluntary Recall: What You Need to Know
About one-third of Americans have chronic high blood pressure, making it one of the most common health conditions in the United States. Recently, popular medications to treat high blood pressure have been under scrutiny by the FDA for containing cancer-causing impurities.
In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of known carcinogens. Now, almost a year later, manufacturer Torrent Pharmaceuticals expands its voluntary recall for the 5th time. This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets.
This is part of an ongoing issue with angiotensin II receptor blocker (ARB) medications. In addition to losartan, other ARB medications valsartan and irbesartan have been frequently recalled, also due to trace amounts of carcinogens found in testing.
Here’s what you need to know about these recalls.
What is losartan?
One of the most popular prescription medications in the U.S., losartan is used to treat high blood pressure and reduce the risk of stroke. It is also used to treat kidney disease in people with diabetes. As an angiotensin receptor blocker (ARB), losartan helps to relax blood vessels, making it easier for the heart to pump blood to the body.
Why were these products recalled?
Losartan was recalled due to impurities found while testing finished products. The impurity found in these batches is N-Methylnitrosobutyric acid (NMBA). This is the third type of impurity to cause recalls of these medications. The other two are N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). All three are classified as a probable human carcinogen, meaning they may cause cancer. The FDA strictly regulates the maximum amount of carcinogens found in prescription medications.
Which losartan products were recalled?
A total of 5 batches of drugs were affected by this recall. Batches are identified by their lot number, which designates a time frame in which the medication was manufactured. Here’s the information for the recalled products:
| Name and strength | National Drug Code (NDC) | Lot Number | Expiration Date |
|---|---|---|---|
| Losartan, 50mg | 13668-409-10 | 4DU2E009 | December 2020 |
| Losartan, 100mg | 13668-115-90 | 4DU3E009 | December 2020 |
| Losartan, 100mg | 13668-115-10 | 4DU3E018 | February 2021 |
| Losartan / Hydrochlorothiazide, 50 mg / 12.5 mg | 13668-118-90 | BEF7D051 | November 2020 |
| Losartan / Hydrochlorothiazide 100 mg / 25 mg | 13668-115-90 | 13668-118-90 | July 2020 |
These batches only reflect the most recent recall by Torrent Pharmaceuticals. You can find a complete list of ARB medications that have been recalled in the past year here.
How do I know if my medication was recalled?
To find out if your medication has been recalled, check if the recalled drug name and associated manufacturer match those on the label of your prescription. Then, check to see if your drug’s NDC and lot number match as well. If you can’t find the information on your medication, contact your pharmacy.
What do I do if my medication was recalled?
If your medication is part of this recall, do not stop taking your medication yet. Talk to your healthcare provider first to determine the next steps. Remember that not all losartan products were affected by this recall.
If you have a recalled product, you can return it to your pharmacy. The pharmacy will send the medication back to the wholesaler and give you a replacement medication.
To read more about this recall, check out this FDA page, or this page for all recall updates.
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