Certain Lots of Heart Medicine Irbesartan Recalled Due to Contamination with Carcinogen


By Sandra Dalton, Staff Writer

The U.S. Food and Drug Administration (FDA) has issued a safety alert warning irbesartan users that certain lots of the drug have been voluntarily recalled by Sciegen Pharmaceuticals. Irbesartan is used to treat high blood pressure. Patients taking the drug should talk to their doctors before discontinuing use. Not all irbesartan products are being recalled. The recall is due to contamination of the active ingredient manufactured by Aurobindo Pharma Limited (APL). The contaminant may cause cancer.

Affected Irbesartan

Certain lots of Irbesartan Tablets, USP in 75mg, 150mg, and 300mg were recalled. Recalled lots of irbesartan have “Westminster Pharmaceuticals” or “GSMS INC.” on the label. The tablets themselves are oval in shape, white, and debossed with the markings SG 160, SG 161, or SG 162. Expiration dates for the recalled lost are as follows:

  • 75mg Western Pharmaceuticals – September 19
  • 75mg GSMS – September 19
  • 150mg Western Pharmaceuticals – September 19, February 20
  • 150mg GSMS - September 19, November 19, February 20, May 20
  • 300mg Western Pharmaceuticals – September 19, February 20
  • 300mg GSMS - September 19, November 19, February 20

The Reason for the Recall

The recall was issued due to contamination with N-nitrosodiethylamine (NDEA), which has been classified as a probable human carcinogen. It is worth noting that valsartan, which is also used to treat high blood pressure, was recalled for the same reason in July of this year. The FDA is now testing all drugs containing valsartan, and similar active ingredients, for the impurity. 

If you believe that you have been armed by Irbesartan or any defective drug, please talk to an experienced defective drug attorney right away to learn more about your rights.

Add new comment