Endo Voluntarily Recalls One Lot of Clonazepam Tablets Following Mislabeling Error

Endo, a specialty pharmaceutical company, recently issued a voluntary recall of one lot of clonazepam orally disintegrating tablets, an approved antiseizure medication, due to a mislabeling issue with packaging. All told, the product lot showed an incorrect strength on the cartons of some packs, with strengths of 0.125 mg and not 0.25 mg.¹

In the update, the company noted that the blister strips inside the product pack reflect the correct strength of 0.25 mg. There are risks associated with an increased overdose of clonazepam, including significant sedation, dizziness, ataxia, and confusion. In addition, patients exposed to this 2-fold overdose would be at risk for possibly life-threatening, respiratory depression, especially in those with concomitant pulmonary disease, those who have prescribed dosing near maximal dosing, and those taking other medications that could cause additional respiratory depression.

Clonazepam orally disintegrating tablets are indicated as an adjunct treatment for those with Lennox-Gastaut syndrome, akinetic and myoclonic seizures, as well as panic disorder. To date, there have been no reports of adverse events associated with the product lot recall, which was distributed through wholesale distributors to retail pharmacies nationwide. The recall impacts product lot 550147301, which has an expiration date of August 2026.

Consumers in possession of any unused prescribed 60 tablet cartons of clonazepam orally disintegrating tablets, 0.25 mg, which may also appear as the 0.125 mg dose bearing the aforementioned lot number, have been advised to discontinue use of the product. Patients who inadvertently took a 0.25 mg dose rather than the intended 0.125 mg dose are advised to consult a physician.

Clonazepam, taken orally by mouth, belongs to a group of medications called benzodiazepines. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants can cause severe drowsiness, breathing problems, coma, and death. Clonazepam orally disintegrating tablets can also cause physical dependence and withdrawal reactions, especially if taken for several days to several weeks. Like other antiepileptic medicines, clonazepam orally disintegrating tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.²

The most common adverse events related to clonazepam include drowsiness, problems with walking and coordination, dizziness, depression, fatigue, and problems with memory. In addition, patients on the medication should not drive, operate heavy machinery, or do other dangerous activities until they understand how the medication impacts them.

REFERENCES
1. Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton. News release. FDA. July 17, 2024. Accessed July 23, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp?utm_medium=email&utm_source=govdelivery
2. Clonazepam: medication guide. Par Pharmaceutical. Updated January 2024. Accessed July 23, 2024. https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=1aef0069-80ea-483d-ac70-c8d485462c5https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=1aef0069-80ea-483d-ac70-c8d485462c5