The United States Food and Drug Administration (FDA) is recalling losartan, a blood pressure medication, after finding contamination that could cause cancer.
The voluntary recall of losartan potassium hydrochlorothiazide by pharmaceutical company Sandoz Inc., is for 100 milligram/25 milligram tablets with the lot number JB8912. The affected product was distributed nationwide on or after October 8, 2018. In total, the recall encompasses less than 1% of the national losartan drug products. The FDA reports that so far, Sandoz has not received any reports of adverse events related to the drug.
The losartan lot being recalled was found to be contaminated with trace amounts of an impurity, N-nitrosodiethylamine (NDEA). NDEA is an organic chemical that is classified as a probable human carcinogen and is used to make liquid rocket fuel. It’s also a byproduct of pesticide manufacture and of fish processing.
If this sounds familiar, it’s because the FDA recently recalled blood pressure drug irbesartan for the exact same reason. That product callback followed on another NDEA-related drug recall, for another blood pressure medication, valsartan, back in July.
As with previous recalls, the FDA cautions that if you take these hypertension medications, it is important to consult a pharmacist or physician before discontinuing use of the drug, as that may have even more severe effects than taking a contaminated pill.