The U.S. Food and Drug Administration (FDA) has ordered the immediate recall of clonazepam capsules distributed in pharmacies nationwide due to labeling errors, the agency announced in an official statement.

 

The issue affects specific batches manufactured by Endo, Inc., where the external packaging displays incorrect information about the medication's concentration. However, the tablets and blister packs inside the packaging accurately reflect the correct concentration for each batch. The affected lots include various presentations of Clonazepam ODT (C-IV) with dosages of 0.125 mg, 0.25 mg, 1 mg, and 2 mg.

 

You may also be interested in the Spanish version: La FDA retira pastillas de clonazepam en EE.UU.

 

FDA Warning
The FDA cautions that the inadvertent consumption of an incorrect dose could lead to adverse effects, such as excessive sedation, dizziness, confusion, ataxia, and, in severe cases, potentially fatal respiratory depression. These risks are heightened for individuals with preexisting health conditions or those taking other medications that may also depress respiratory function.

 

Recommendations for Consumers
Consumers in possession of these batches should immediately discontinue use and return the product to the pharmacy where it was purchased. Those who have already consumed the medication are advised to consult a healthcare professional to assess potential risks.

 

For more information on the affected lots and return procedures, visit the FDA's website or contact your healthcare provider.