The United States Food and Drug Administration is recalling the blood pressure medication losartan after finding contamination that could cause cancer.
The FDA and Sandoz announced on Friday that the Novartis unit is recalling one lot of losartan that was manufactured by its Lek Pharmaceuticals unit in Ljubljana, Slovenia, because its contains N-nitrosodiethylamine (NDEA), a suspected carcinogen. NDEA along with N-Nitrosodimethylamine (NDMA) are two probable human carcinogens that the FDA has discovered can be created during manufacturing under certain conditions.
The voluntary recall 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.
FDA officials say they have not received any reports that the trace amounts of the two impurities have resulted in adverse events but are pushing for the recalls as a matter of caution. Sandoz’s losartan drug products make up less than 1% of the total losartan drug products in the U.S. market, officials said.
If all this sounds familiar, you’re not imagining things. 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.