Endo, a pharmaceutical firm based in Pennsylvania, has initiated a nationwide recall of its widely used anxiety drug, clonazepam, due to a potentially fatal labeling mistake. The company revealed this week that it is broadening its recall after finding that some medication cartons were inaccurately labeled with the wrong strength and drug code details.
The extended recall impacts 16 batches of Clonazepam Orally Disintegrating Tablets, USP (C-IV), with dosages varying from 0.125 milligrams to 2 milligrams. Clonazepam, a benzodiazepine, is frequently prescribed for panic disorders and certain types of seizures.
Each recalled medication package contains 10 blister strips, with each strip containing six tablets. The affected batches are due to expire between August 2026 and February 2027.
Endo has cautioned that taking a higher dose of clonazepam than recommended could result in increased drowsiness, confusion, dizziness, reduced reflexes, and loss of muscle control or strength. More severe risks include significant, potentially fatal breathing difficulties, especially for individuals with respiratory disease, those prescribed the maximum dose, and those taking other medications that affect breathing.
Despite the severe potential outcomes of the mislabeling, Endo has not received any reports of issues related to the recall as of Monday. The company first announced a recall in July for a single batch of clonazepam, attributing the error to a third-party packager.
The mislabeled cartons displayed a product strength of 0.125 mg instead of the correct 0.25 mg. However, the blister strips inside the package were labeled with the correct strength, according to Endo. The recalled cartons also list Par Pharmaceutical of New York as the distributor. Par Pharmaceutical marketed clonazepam before the product was acquired by Endo.
Endo is advising retailers not to sell the affected products and urging consumers not to take them. Anyone who believes they may have taken an incorrect dose of clonazepam is advised to consult a physician. For questions about the recall, individuals can call (855) 589-1869 or email rxrecalls@inmar.com.