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FDA Expands Losartan Recall Over Possible Cancer Risk

Riddle Brantley LLP   |  June 18, 2019   |  

Drug manufacturer Teva Pharmaceutical and the Food & Drug Administration (FDA) have expanded a voluntary recall of losartan potassium tablets, a common medication used to treat high blood pressure, based on contamination by potentially cancer-causing impurity called NMBA.

Losartan Recall Expanded - Riddle & BrantleyN-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is believed to increase the risk of cancer to patients exposed to products containing high levels of the impurity.

Losartan potassium tablets are commonly used to treat hypertension (high blood pressure) and nephropathy in Type 2 diabetic patients.

Losartan recall details

Losartan potassium tablets affected by the recall are described as:

  • Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and “>” on the other side.
  • Losartan potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and “>” on the other side.

Teva Pharmaceuticals and the FDA advise patients taking losartan potassium tablets to consult with their prescribing doctor. Because the risk associated with going off the medication can be significant, patients are advised to continue taking the drug unless a doctor recommends otherwise.

Teva Pharmaceuticals first began recalling losartan potassium tablets in April 2019.

For more information on this developing story, please visit the FDA losartan recall page.

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