Blood Pressure Drug Recalled

Jubilant Cadista Pharmaceuticals Inc is recalling 4 lots of irbesartan tablets because samples failed to meet dissolution specifications during testing, according to the August 3, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Jubilant Generics Ltd Roorkee, India, marketed by Jubilant Cadista Pharmaceuticals, Salisbury, MD, and distributed throughout the United States:

• irbesartan tablets, 75 mg, in 90-count bottles (NDC 59746-447-90), from lots IB120012A, IB120013A, and IB120014A (Exp. 8/22); and
• irbesartan tablets, 150 mg, in 90-count bottles (NDC 59746-448-90), from lot IB220023A (Exp. 8/22).

Jubilant Cadista Pharmaceuticals voluntarily initiated the recall July 18, 2022. On July 26, 2022, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Irbesartan is a prescription medication used to lower blood pressure in patients with hypertension. Irbesartan is also used to treat diabetic nephropathy.