Blood Pressure Tablets Recalled

Unspecified problems with blister packaging have prompted Glenmark Pharmaceuticals Inc to recall numerous lots of telmisartan and hydrochlorothiazide tablets, according to the August 17, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Glenmark Pharmaceuticals Ltd, Madhya Pradesh, India, for Glenmark Pharmaceuticals USA, Mahwah, NJ, and distributed throughout the United States:

• telmisartan and hydrochlorothiazide tablets, 80 mg/12.5 mg, 30 tablets (NDC 68462-841-13), from lots 17210929 and 17210930 (Exp. 5/23), 17211203 (Exp. 6/23), and 17211643, 17211646, and 17211649 (Exp. 8/23); and
• telmisartan and hydrochlorothiazide tablets, 80 mg/25 mg, 30 tablets (NDC 68462-842-13), from lots 17210935 and 17210936 (Exp. 5/23), 17211206 (Exp. 6/23), and 17211652, 17211655, and 17211658 (Exp. 8/23).

Glenmark Pharmaceuticals voluntarily initiated the recall June 29, 2022. On August 5, 2022, the FDA designated the recall Class II, communicating use of the tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Telmisartan and hydrochlorothiazide tablets are a prescription diuretic and antihypertensive medication used to lower high blood pressure.