Blood Pressure Drug Recalled for Foreign Substance

Strides Pharma Inc. is recalling 2700 bottles of losartan potassium tablets after a piece of blue plastic was found embedded in a tablet, according to the July 12, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects losartan potassium tablets, 25 mg, 1000 film-coated tablets per bottle (NDC 64380-933-08), from lot 7901903A (Exp. 4/24). The drug was manufactured Vivimed Life Sciences Private Limited, Tamil Nadu, India, and distributed throughout the United States.

Strides Pharma voluntarily initiated the recall June 26, 2023. On July 6, 2023, the FDA designated the recall Class II, signaling use of the affected product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Losartan is a prescription angiotensin receptor blocker indicated for use in patients with hypertension and nephropathy in patients with type 2 diabetes and a history of hypertension.