The FDA has issued an urgent and immediate recall for Clonazepam. The orally disintegrating tablets are mislabeled and may contain the incorrect strength. Consumers who are prescribed Clonazepam should check their medication immediately. Otherwise, they may inadvertently take a double dose of the drug.
As of the writing of this notice, the FDA has not announced any reports of adverse events related to this recall.
SUMMARY
Date of Recall:
Announced: July 16, 2024
Public Notification: July 17, 2024
Name(s) of Drug:
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets
Company Name:
Endo USA, Inc
Drug Indication:
Anxiety
Panic Disorder
Lennox-Gastaut Syndrome
Akinetic seizures
Myoclonic seizures
Product Description
Clonazepam is available by prescription only and is distributed by pharmacies nationwide. It is packaged in white cardboard boxes that contain blister packages inside. The lots pertaining to this recall are contained within exterior packaging that indicates a product strength of 0.125mg when it is actually 0.25mg. The blister strips contained within the packaging bear the correct dosage of 0.25mg.
Reason for Recall
The recall was initiated after a third-party packaging error led to incorrect drug labeling. 0.25mg tablets are contained within packaging labeled with 0.125mg. While the interior blister packaging is correctly labeled, the exterior packaging may lead consumers to unknowingly consume a double dose of the drug.
Impacts
Consumers who unknowingly ingest the incorrectly labeled drug may experience serious side effects related to incorrect dosing.
Consuming a double dose of the drug may lead to:
- Sedation
- Dizziness
- Ataxia
- Confusion
- Respiratory depression (slowed breathing)
- Interactions with other medications
These effects are particularly dangerous for children and people living with pulmonary disease.
Recall Product Information
Consumers prescribed Clonazepam should check their stock to confirm if they are included in the recall. Those who have used or currently possess drugs from the listed lots must read further for instructions on participating in the FDA recall.
| Product Description | Count | Lot Number | Expiration Date |
| Clonazepam Orally Disintegrating Tablets, USP 0.25mg | 60 Count | 550147301 | August 2026 |
| Clonazepam Orally Disintegrating Tablets, USP 0.125mg | 60 Count | 550147301 | August 2026 |
www.fda.gov
Are you in possession of drugs included in the recall? Here’s what you should do:
Consumers
- Call your pharmacy for a replacement medication immediately. Stop using the recalled medication.
- Notify your doctor if you have used the recalled medication.
- Monitor your health for any adverse symptoms and seek medical attention if you have concerns.
- If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- If you have questions, contact Inmar at 1-877-890-0765. They are available Monday through Friday from 9 a.m. to 5 p.m. ET. Additionally, you can reach them by email at rxrecalls@inmar.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock included in the recall.
- Notify affected consumers of recalled batches that they have already or will receive.
- If you have questions, contact Inmar at 1-877-890-0765. They are available Monday through Friday from 9 a.m. to 5 p.m. ET. Additionally, you can reach them by email at rxrecalls@inmar.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and consider removing stock included in the warning.
- Notify affected retailers of recalled batches that they have already or will receive.
- If you have questions, contact Inmar at 1-877-890-0765. They are available Monday through Friday from 9 a.m. to 5 p.m. ET. Additionally, you can reach them by email at rxrecalls@inmar.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
