FDA Announces Voluntary Clonazepam Recall
The Benzodiazepine, a Generic Form of Klonopin, Had a “Life-Threatening” Labeling Error
A vital safety alert was issued for Clonazepam users. Endo, Inc., a pharmaceutical company based in Pennsylvania, has recalled its seizure medication, Clonazepam tablets.
The recall is due to a mistake in labeling the product strength on the carton. Such a serious error could lead to life-threatening consequences for thousands of users.
The recall is part of an FDA investigation. Endo, Inc. expanded its initial voluntary recall from July 16. The FDA announced the expanded recall in an alert on Nov. 19.
Urgent Warning for Clonazepam Users—Verify Your Dose Now
If you use clonazepam benzodiazepine, check your product’s labeling immediately. People who take a higher dose of Clonazepam could face serious health risks, including:
– Extreme drowsiness
– Confusion
– Dizziness
– Slowed reflexes
– Lack of coordination
– Low muscle tone
– Life-threatening respiratory depression
There is a significant chance of life-threatening respiratory depression:
- Particularly for individuals with lung conditions
- Those already prescribed high doses of Clonazepam
- Patients taking other medications that suppress breathing
If you have experienced a severe adverse reaction from Clonazepam, contact 1-800-967-8529 for a 100% Free and Confidential consultation. The Yost Legal Group is a highly experienced Product Liability law firm. Our Clonazepam lawyers will investigate what happened and fight to seek the justice and financial compensation you deserve.
What Is Clonazepam?
The drug Clonazepam is a generic drug under the benzodiazepine class of depressant drugs.
Depressants: These types of drugs affect the brain’s activity. They slow neurotransmission levels and decrease electrical activity in the brain. Depressants also inhibit an individual’s ability to feel arousal and stimulation.
This reduction in brain activity is why depressant drugs can be effective when used correctly. A medical professional prescribes them to relieve disorders and symptoms such as:
- Anxiety disorders
- Depression
- Insomnia
- Obsessive-compulsive disorder
- Seizures
Alcohol, benzodiazepines, and cannabis are some of the most common types of depressant drugs.
Benzodiazepines: Benzodiazepines, known as “benzos,” are a class of depressant drugs. This type of drug derives its name from its chemical compound, which is a fusion of benzene and diazepine rings.
Medically, benzodiazepines are most often used to treat anxiety and panic disorders, insomnia, and seizures. Common types of benzodiazepines include alprazolam (Xanax®), clonazepam (Klonopin®), and diazepam (Valium®).
Clonazepam is a generic benzodiazepine sold under the brand name Klonopin®, which more people are probably familiar with. This recall, however, pertains only to the generic version.
Severe Health Risks Linked to Incorrect Clonazepam Dosage
Clonazepam is often used to treat anxiety disorders, bipolar mania, and seizures. Anyone with these ailments and conditions needs regular help. For some people, it might be difficult to make it through a day without their prescribed medication.
Pharmaceutical companies have a clear duty to ensure their products are safe. This includes items people apply, ingest, or inject. They must also make sure their product labels are accurate. These labels tell people how to use their medications safely.
The recall for Clonazepam relates to the tablet version, as the drug is most often taken orally.
The packaging had a labeling mistake. The company said it was “possibly life-threatening.” This was also noted in the FDA safety warning. If a user took the wrong amount of the medication, it could be dangerous. This happened because the number of milligrams in each tablet was incorrect.
If you or someone you know may have been affected, seek medical attention immediately. Contact The Yost Legal Group’s “Dangerous Drugs” division to learn about your legal rights.
Life-Threatening Clonazepam Risks—Know Your Legal Rights
This was no small mistake. In 1960, Clonazepam was patented and became available in the United States in 1975. Doctors have prescribed the drug often since it has been on the market for decades.
According to ClinCalc.com, Clonazepam was the 57th most prescribed drug in the United States in 2022. More than 11.5 million prescriptions of Clonazepam were made out to nearly 2 million patients in 2022.
This mislabeling put millions of people at risk. Furthermore, it was not the first time Endo was derelict in its duties regarding labeling its clonazepam packaging.
The product recall focuses on Clonazepam drug side effects, one of which can result in death from Clonazepam. The product liability lawyers at The Yost Legal Group are here to help. Many FDA recalls exist; the highest level occurs when the FDA issues an FDA Black Boxed Warning. This usually happens when a company is about to remove a drug from the market.
The First Clonazepam Recall of 2024
On July 17, 2024, the FDA published a safety alert that it voluntarily recalled many orally disintegrating drugs due to mislabeling.
Endo announced that the lot it was recalling included packaging that under-reported the strength of each tablet:
“The product lot [550147301] is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager.”
Regardless of the mistake by the “third-party packager,” Endo bears responsibility as the drug manufacturer and the employer of the company that packages its medication.
However, it was just one lot and one recall. As Endo noted in its statement, “to date [the company] has not received any reports of adverse events associated with this product lot recall.”
But it would not remain just one lot and one recall for much longer.
If a defective drug harmed you or a loved one, you may have a case and be entitled to compensation. Call or text the experienced defective drug lawyers at The Yost Legal Group today for a free consultation: 410-659-6800.
The Second Clonazepam Recall of 2024
As previously stated, Endo voluntarily recalled Clonazepam in November 2024, and the FDA ran a safety alert. The second recall, however, was not just to announce the recall of a second lot. The alert included a whopping 16 lots of the drug.
The table below includes the product description (Clonazepam Orally Disintegrating Tablets), the National Drug Code number, and the lot number.
Potential Product Description / NDC Number Lot Number Expiry Date
Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 550176501 Feb 2027
550176601 Feb 2027
Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 550174101 Jan 2027
Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 550142801 Aug 2026
550142901 Aug 2026
550143001 Aug 2026
550143101 Aug 2026
550143201 Aug 2026
550143301 Aug 2026
550143401 Aug 2026
550147201 Aug 2026
550147401 Aug 2026
Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 550145201 Aug 2026
550175901 Feb 2027
550176001 Feb 2027
550176201 Feb 2027
Again, Endo placed the blame on its third-party packager:
“Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below 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.”
Serious Side Effects from Clonazepam? We Can Help
Endo is responsible for its medication, and for the third-party packager/s, it hires to label its products. Although the actual medication is not defective, it is still vital to ensure the labeling is correct so that people using the drug can do so safely.
This repeat of negligence with mislabeling puts real people at risk. As of 2022, nearly 2 million people were prescribed Clonazepam, and now there are 16 recalled lots. Endo put its customers in harm’s way.
We do not know how the packages got the wrong information. However, we have seen how small details can be missed at big pharmaceutical companies. Some companies cut corners to save money, which harms people. The result is almost always putting innocent people at risk.
Clonazepam Adverse Reaction? Seek Justice Today
The Yost Legal Group has a long history of representing individuals and their families after a defective drug altered someone’s life.
Drug companies are billion-dollar multinational corporations with some of the best pharmaceutical lawyers in the world. A skilled and experienced defective drug lawyer must handle the complex legal issues when suing a Big Pharma company.
That is where The Yost Legal Group’s accomplished defective drug lawyers factor into the equation. As leading personal injury attorneys, we file product liability lawsuits every day. Let us file your Clonazepam claim.
Many cases involve prescription drugs because of “failure to warn” and “serious pharmaceutical side effects.”
If a defective drug has harmed you or a loved one, please get in touch with The Yost Legal Group today. Our defective drug lawyers will start working on your case right away. They will help you understand your rights to seek the compensation and justice you deserve. Call or text us at 410-659-6800.
All consultations are free, and you do not owe us anything unless we take on and win your case.
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