Some Clonazepam Recalled for Serious Labeling Mistake
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Common Anxiety Drug Recalled for ‘Possibly Life-Threatening’ Labeling Error

Dissolvable clonazepam (the generic form of Klonopin) may have the wrong dosage on the packaging.
Common Anxiety Drug Recalled for ‘Possibly Life-Threatening’ Labeling Error
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Published on November 22, 2024
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The U.S. Food and Drug Administration (FDA) announced a recall of some lots of orally disintegrating clonazepam tablets (the generic form of Klonopin), due to package mislabeling that could pose “possibly life-threatening” breathing problems.

The maker of the drug, Endo, said that some lots of this common anxiety medication “contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.”

The following lots have been recalled:

  • Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02:
    Lot numbers 550176501, 550176601
  • Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02:
    Lot number 550174101
  • Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02:
    Lot numbers 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550147201, 550147401
  • Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02: 
    Lot numbers 550145201, 550175901, 550176001, 550176201

What Is the Risk of Taking This Medication?

The FDA announcement notes that adults and children who accidentally take a higher dose of clonazepam than intended could be at risk of:

  • Significant sedation
  • Confusion
  • Dizziness
  • Diminished reflexes
  • Ataxia (loss of muscle control and clumsiness)
  • Hypotonia (low muscle tone or weakness)

The FDA notes that there is “reasonable probability” for significant, possibly life-threatening breathing issues (respiratory depression), especially for:

  • people who also have pulmonary disease (COPD)
  • those prescribed a high dose
  • those also taking other medications that could cause additional respiratory depression

To date, the company has not received any reports of health complications associated with this recall.

The affected lots are no longer being sold, but people who already have this medication should not use it.

If you took a stronger dose of clonazepam than you intended, call your doctor, the FDA advises.

Anyone with questions regarding this recall can contact the company by phone at 855-589-1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com.

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Resources
  1. Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling. U.S. Food and Drug Administration. November 19, 2024.