Blood Pressure Drug Recalled

Nearly 120,000 bottles of telmisartan tablets distributed in Tennessee, Rhode Island, and Puerto Rico are under recall for being out of specification for blend uniformity, according to the March 20, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 40-mg telmisartan tablets in 30-count bottles (NDC 42571-227-30) from lots SFBG024 and SFBG025 (Exp. 5/31/24). The tablets were manufactured for Micro Labs USA Inc., Somerset, New Jersey, by Micro Labs Limited, Goa, India. 

Micro Labs Limited voluntarily initiated the recall on February 9, 2024. On March 14, 2024, the FDA designated the recall Class II. Per the classification, use of the tablets could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Telmisartan is a prescription drug indicated to lower blood pressure in patients with hypertension and to reduce cardiovascular risk in at-risk patients unable to take angiotensin-converting enzyme (ACE) inhibitors.