FDA Issues Class II Recall for Carvedilol Tablets Due to Nitrosamine Contamination

The US Food and Drug Administration (FDA) has issued a Class II recall for multiple strengths and packaging formats of Carvedilol Tablets, USP—including 3.125 mg, 12.5 mg, and 25 mg doses—manufactured by Glenmark Pharmaceuticals Ltd. in India and distributed by Glenmark Pharmaceuticals Inc., USA. The recall was initiated due to the presence of N-Nitroso Carvedilol I, a nitrosamine impurity found at levels above the FDA’s acceptable intake limit of 4.0 ppm. The affected products span multiple lot numbers and expiration dates through June and July 2026, totaling over 88 000 bottles distributed nationwide.

Glenmark voluntarily initiated the recall on August 6 and 7, 2025, with the FDA classification confirmed as Class II on August 12 and 14, 2025. A Class II recall indicates that the use of the product may cause temporary or medically reversible adverse health effects, though serious health risks are not likely. The presence of elevated nitrosamine levels—classified as probable human carcinogens—warrants prompt removal from the supply chain, especially in long-term medications like carvedilol that are taken chronically for heart conditions. Although no press release has been issued, consignees have been notified by letter.

Carvedilol is a non-selective beta-blocker with alpha-blocking activity used to treat hypertension, heart failure, and left ventricular dysfunction following myocardial infarction. Pharmacists should identify and quarantine the affected lot numbers, including those under NDCs 68462-162-01, 68462-162-05, 68462-164-05, and 68462-165-05, and work with prescribers to ensure continuity of care using unaffected inventory or alternative therapies.