FDA Recalls Carvedilol Tablets Due to Impurity Concerns

Glenmark Pharmaceuticals and RemedyRepack Inc have issued a voluntary nationwide recall of multiple lots of carvedilol tablets due to the presence of N-Nitroso Carvedilol Impurity-1 (NNCI-I), which exceeds the US Food and Drug Administration’s (FDA’s) recommended intake limits. The affected products include Carvedilol Tablets USP, 25 mg, and 12.5 mg, as well as repackaged 25 mg blister packs. The recall, classified as Class II by the FDA, indicates that exposure to the impurity may cause temporary or medically reversible adverse health effects, though the likelihood of serious harm is low. The recall was initiated on January 22 and January 24, 2025, and is currently ongoing.

Carvedilol, a beta-blocker commonly prescribed for the treatment of hypertension and heart failure, was manufactured for Glenmark Pharmaceuticals and repackaged by RemedyRepack Inc. The recall affects numerous lot numbers with expiration dates ranging from February 2025 to February 2026. Glenmark’s products were distributed nationwide in the US, while RemedyRepack’s repackaged carvedilol was distributed in Florida. Notifications were sent to affected parties via letter, but no public press release has been issued.

Carvedilol is primarily used to manage high blood pressure, reduce the risk of mortality in patients with heart failure, and improve survival following a heart attack. Pharmacists should be aware of this recall to prevent the distribution of affected products and to counsel patients on potential alternatives. Healthcare professionals are advised to review their inventories and report any adverse reactions or quality concerns to the FDA’s MedWatch program.