A widely used prescription medication for anxiety is facing a nationwide recall after a critical labeling error that could pose life-threatening risks. Endo, a pharmaceutical company based in Pennsylvania, has expanded its recall of clonazepam tablets due to incorrect drug strength and misleading product codes printed on the packaging.
Clonazepam, a benzodiazepine prescribed to manage panic disorders and certain seizure conditions, is distributed in blister packs containing six tablets each. The recall now affects 16 lots of Clonazepam Orally Disintegrating Tablets, USP (C-IV), with dosages ranging from 0.125 milligrams to 2 milligrams. The affected packages have expiration dates between August 2026 and February 2027.
Endo issued the initial recall in July, citing an error by a third-party packager as the root cause of the mislabeling. At the time, only one lot of the medication was recalled. This week, the company announced the recall’s expansion to additional lots after further review. According to Endo, some cartons were labeled as containing 0.125 mg tablets when they actually contained 0.25 mg tablets. Although the blister strips inside reportedly reflect the correct strength, the incorrect labeling on the outer carton poses significant risks.
The Dangers of Mislabeled Medication
Taking a higher dose of clonazepam than prescribed can lead to serious side effects. Endo has warned of increased risks such as drowsiness, confusion, dizziness, weakened reflexes, and loss of muscle strength or control. In more severe cases, consuming an excessive dose may cause respiratory complications, particularly for individuals with pre-existing breathing conditions, those already on the maximum dosage, or patients taking other medications that affect respiratory function. These complications could potentially become life-threatening.
Despite the recall, Endo has not received reports of adverse effects related to the mislabeled cartons as of this week. However, the company is urging consumers and retailers to exercise caution. Consumers who believe they may have taken an incorrect dose of clonazepam are advised to contact their healthcare provider immediately. Retailers are being instructed to pull the affected products from shelves and cease sales to prevent further risks.
What Consumers Should Do
For those with questions or concerns regarding the recall, Endo has provided a dedicated hotline at (855) 589-1869 and an email address, rxrecalls@inmar.com, for assistance. The recalled products are marked as distributed by Par Pharmaceutical of New York, a company previously responsible for marketing clonazepam before Endo acquired the product.
This serves as a sobering reminder of the critical importance of accurate pharmaceutical labeling. While the company works to address the error and prevent similar issues in the future, consumers are urged to double-check their medications and consult a physician if they experience any unusual symptoms.
