Endo Recalls Clonazepam Tablets Due to Mislabeling Error

On November 19, 2024, the FDA announced an expanded recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV)  issued by Endo, Inc. under its Par Pharmaceutical brand. The recall originates from mislabeling issues on product cartons, leading to potential confusion regarding medication strength. While the blister strips and tablets are correctly labeled, the mismatched carton labels could result in patients unintentionally consuming incorrect dosages. Stick around for the full story and learn to ensure safety during recalls.

What happened?

On November 19, 2024, the FDA announced Endo, Inc. expanded its earlier recall of Clonazepam Orally Disintegrating Tablets after discovering mislabeled cartons. The error occurred due to a third-party packaging error, resulting in inconsistencies between carton labels and medication strength. The products were distributed nationwide through wholesale distributors and retail pharmacies.

Products Affected

What caused the issue?

The recall results from a third-party packager’s labeling error that misprinted strength and NDC details on certain product cartons. While no adverse events have been reported, mislabeling raises serious concerns:

• Health Risks:
  • Sedation, confusion, and dizziness from higher-than-intended dosages.
  • Potentially life-threatening respiratory depression for vulnerable patients.
• At-Risk Groups:
  • Patients with pulmonary conditions.
  • Individuals taking other medications that suppress respiration.

Here’s what you should do

If you have any Clonazepam Orally Disintegrating Tablets from the affected lots, take these steps:

• Check the Carton Label: Compare the lot number, strength, and NDC against the recall list.
• Stop Usage Immediately: If your product is listed, discontinue use and consult your doctor if you’ve taken an incorrect dose.
• Return the Product: Contact Inmar, Inc. at 855-589-1869 or email at [email protected] for return instructions.
• Report Adverse Reactions: Submit reports to the FDA’s MedWatch program here.

Behind the brand

Endo, Inc., operating under the Par Pharmaceutical brand, is no stranger to recalls. This announcement is an expansion of Endo’s July 16 recall on Par Pharmaceutical Clonazepam Orally Disintegrating Tablets (C-IV) 0.25 mg tablets due to mislabeling. The issue resided in the fact that Some cartons were mislabeled as containing 0.125 mg tablets, but the blister strips inside the pack contained the correct strength of 0.25 mg. 

In recent weeks Wegmans and Bowl & Basket also announced recalls regarding mislabeling issues. Both brands faced concerns over products that contained undeclared egg allergens, which were not properly disclosed on the labels. This error poses serious health risks to individuals with egg allergies, as even small amounts of allergens can cause severe reactions. These incidents serve as a strong reminder of the need for rigorous quality control measures during the packaging and labeling processes. Recalls like these don’t just pose health hazards—they can also have long-lasting repercussions on a brand’s reputation, affecting consumer trust and loyalty over time. Ensuring accurate labeling should remain a top priority for all manufacturers in the food and pharmaceutical industries.

Ensuring safe medicine practices

This recall serves as a reminder of the delicate balance between innovation and safety in pharmaceuticals. Mislabeling, while often unintentional, can have grave consequences for consumers and the industry at large. Stricter regulations on packaging and labeling are very important while trusting in third-party packagers is key. Brands must prioritize stringent quality checks to prevent errors and safeguard consumer trust.Do you need help navigating ingredient recalls or sourcing high-quality, traceable components? Contact us today to explore how Source86 ensures safe, reliable solutions for businesses like yours!