Mislabeled Drug Under Class I Recall

Endo Pharmaceuticals Inc. is recalling a single lot of clonazepam orally disintegrating tablets because some cartons were mislabeled with an incorrect strength. According to the August 7, 2024, US Food and Drug Administration (FDA) Enforcement Report, the cartons incorrectly read 0.125 mg instead of 0.25 mg. The blister strips inside the product pack state the correct strength of 0.25 mg.

The FDA has designated the recall Class I, advising use of the affected tablets could cause serious adverse health consequences or death.
“Children and adults who are inadvertently prescribed a 2-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion,” Endo stated in a July 16, 2024, company announcement. “There is reasonable probability for significant, possibly life-threatening, respiratory depression, especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.”

The recall affects 8139 cartons of clonazepam orally disintegrating tablets, 0.125 mg, 60 tablets per carton (10 blister cards containing 6 tablets each; NDC 49884-306-02), from lot 550147301 (Exp. 8/31/26). The cartons were distributed throughout the United States and in Puerto Rico by Par Pharmaceutical, Chestnut Ridge, New York. 

Endo voluntarily initiated the recall on July 10, 2024. The FDA designated the recall Class I on July 30, 2024. As of mid-July, Endo had not received any reports of adverse events associated with the recall. 

Clonazepam orally disintegrating tablets are a Schedule IV controlled substance indicated in the treatment of Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. Additionally, the drug is indicated for the treatment of panic disorder.