Recall of Clonazepam Anxiety Drug After Potential Life-Threatening Labeling Error

A voluntary recall in the United States has been issued for clonazepam (the generic name for Klonopin), an anxiety-reducing drug, due to a potentially fatal labeling mistake. The recall involves 16 lots of clonazepam Orally Disintegrating Tablets, which were found to be mislabeled with incorrect strengths and National Drug Code (NDC) numbers. The Pennsylvania-based pharmaceutical company responsible for the drug, Endo, Inc., identified the error after an investigation revealed that a third-party packager was at fault.¹

While no adverse events have been reported as of the recall’s announcement on November 18, 2024, the mislabeling presents serious risks, particularly for patients who might unknowingly take the wrong dose.²

Clonazepam is drug commonly prescribed to treat anxiety, panic attacks, and seizure disorders like epilepsy. It works by increasing the calming effects of gamma-aminobutyric acid (GABA) in the brain, which helps reduce nervous system activity.³ In 2022, the estimated number of clonazepam prescriptions in the U.S. was 11,711,065. The estimated number of patients in the U.S. taking clonazepam was 1,968,091.⁴

Clonazepam Labeling Error Poses Potential Health Risks

The recent labeling mix-up means patients might mistakenly consume a higher dose than intended, which can cause significant side effects.⁵ The U.S. Food and Drug Administration (FDA) has warned that such errors could lead to “life-threatening” respiratory depression, a condition where breathing becomes dangerously slow or shallow, depriving the body of oxygen.⁶ The FDA’s website states:

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.⁷

Taking an incorrect dose of clonazepam could lead to various harmful effects, including extreme sedation, confusion, dizziness, and diminished reflexes. Additionally, patients might experience ataxia (loss of muscle coordination) and hypotonia (low muscle tone). Respiratory depression remains the most concerning risk as it can lead to severe complications, including a lack of oxygen in the bloodstream, which may result in death if not addressed promptly.⁸

The risk is particularly high for individuals who are taking other medications that also slow down breathing, as well as for those who are already prescribed a high dose of Clonazepam. The recall affects clonazepam tablets in four strengths: 0.125mg, 0.25mg, 1mg, and 2mg. The tablets were distributed nationwide in cartons containing 60 tablets, packed into 10 blister strips of six tablets each.

All affected lots are identified with specific NDC numbers and lot numbers, which are listed in the recall notice. For consumers who have these products, the FDA and Endo strongly advise that they stop using the recalled tablets immediately and contact a healthcare provider if they suspect they have taken the wrong dose.⁹

Consumer Guidance

Endo initiated the recall voluntarily after identifying the labeling error during an ongoing investigation. While the company confirmed that only a limited number of cartons were affected, the recall was expanded once it became clear that the issue had broader implications. The FDA has instructed consumers who have purchased the recalled products can contact Inmar, Inc. at 855-589-1869 or via email at [email protected] for assistance.¹⁰

This incident underscores the critical importance of accurate labeling in the pharmaceutical industry, especially for drugs like clonazepam, where dosing errors can have life-threatening consequences.

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