Endo, a Pennsylvania-based pharmaceutical company, has issued a nationwide recall of its popular anxiety medication, clonazepam, due to a potentially life-threatening labeling error. The company announced this week that it is expanding its recall after discovering that some drug cartons were labeled with incorrect strength and drug code information.
The expanded recall affects 16 lots of Clonazepam Orally Disintegrating Tablets, USP (C-IV), with doses ranging from 0.125 milligrams to 2 milligrams. Clonazepam, a type of benzodiazepine, is commonly prescribed for the treatment of panic disorders and certain types of seizures.
Each package of the recalled medication contains 10 blister strips, with each strip holding six tablets. The affected lots are set to expire between August 2026 and February 2027.
Endo has warned that consuming a higher dose of clonazepam than prescribed could lead to increased sleepiness, confusion, dizziness, diminished reflexes, and loss of muscle control or strength. More seriously, there is a risk of significant, potentially life-threatening breathing difficulties, particularly for individuals with respiratory disease, those prescribed the maximum dose, and those taking other medications that affect breathing.
Despite the serious potential consequences of the mislabeling, Endo has not received any reports of problems related to the recall as of Monday. The company initially announced a recall in July for a single lot of clonazepam, attributing the error to a third-party packager.
The mislabeled cartons indicated 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.