Torrent Pharmaceuticals Limited said its Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, are affected by the recall.
The ingredient detected was identified as N-Methylnitrosobutyric acid (NMBA), a known animal and potential human carcinogen. The company said the recall only affects products found to have more than the FDA-allowable amount of NMBA.
The company issued an initial recall in December, followed by two more in January and March. The fourth recall includes an additional 36 lots of Losartan Potassium Tablets USP and 68 lots of Losartan Potassium/hydrochlorothiazide Tablets, USP.
A full list of the impacted products can be found here.
According to the recall notice posted on the FDA website, the company has not received any reports of adverse reactions related to the recall. The medication is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic patients. Patients are advised to avoid sudden stoppage of medication, and to consult their pharmacist or physician.