FDA Expands Voluntary Clonazepam Recall — What You Need to Know

Those with a prescription for Endo, Inc.'s Clonazepam will want to take notice after the U.S. Food and Drug Administration (FDA) issued a nationwide recall. The decision was announced on Nov. 18, 2024, and includes certain strengths of the medication and several different lot numbers.

Please note that this recall is not meant to serve as a substitution for medical advice, and you should contact your doctor immediately if you have questions about your prescription.

With the recall including multiple different variations of the product, you'll want to keep reading to learn more about the recall, including the exact doses impacted by the error and what you should do if you have any questions.

The FDA released the details of the recall in a statement on Nov. 19, 2024, explaining how Endo, Inc. would expand an existing recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) over concerns that the packaging had been mislabeled with the incorrect dosing.

According to the statement, certain product lots contained an incorrect National Drug Code (NDC) number and incorrect pill strengths.

The recall includes dosage amounts of 2mg, 0.125mg, 0.25mg, and 1mg. For a full list of the lot numbers impacted by the recall you can visit the FDA's website. 

The makers of Clonazepam are blaming a third-party company that it says made the mistake during the packaging process of the exterior containers. The blister packs inside the pill packages do reflect the correct dosage.

The FDA is advising those who have the product at home to discontinue usage. Anyone with questions is being asked to reach out to their physicians directly or to call the company at 855-589-1869.

Taking the wrong prescription can be harmful to both children and adults because a higher dose could cause more intense side effects. According to the FDA, some of those side effects include but aren't limited to:

• Confusion
• Diminished reflexes
• Ataxia

There is also the possibility that some people could experience life-threatening complications, especially those who are taking other medications that could have a negative interaction with the higher dose.

When it comes to deciding between Xanax or Clonazepam, the decision of which medication to take should be carefully discussed with your doctor. That's because, while similar, Medical News Today says that these two benzodiazepines work in different ways.

For example, Xanax is typically used as an antianxiety and antidepression medication. It can be used to help reduce both the intensity and frequency of panic attacks.

Clonazepam, on the other hand, can also be used to help treat seizure disorders, and it serves as an anticonvulsant and antiepileptic medication. It's also frequently used to help with panic disorders as well.

If you're curious about which drug is safer for you to take, you'll want to meet with your doctor to discuss your options.

Not only will you both need to weigh the benefits of using either one of these medications to treat your existing symptoms, but you'll also need to discuss if there are any ways that either drug could interact with any additional prescriptions you may be taking.