Pharmaceutical Company Issues Recall Over Critical Medication Labeling Mistake

Black keyboard with "Product Recall" yellow key.

A life-threatening labeling error has led Endo Pharmaceuticals to issue a nationwide recall of their clonazepam tablets, raising questions about consumer safety standards.

At a Glance

Endo expands recall on clonazepam tablets due to incorrect labeling of drug strength.
The recall involves 16 lots with doses ranging from 0.125 to 2 mg.
Incorrect labeling could lead to significant health risks including severe respiratory effects.
No adverse reactions reported as of now, but consumers are advised to halt consumption.
The initial recall began in July due to a third-party packaging error.

Scope of the Recall

Endo Pharmaceuticals, based in Pennsylvania, has broadened its recall of clonazepam Orally Disintegrating Tablets due to incorrect labeling of drug strength and erroneous drug code on packaging. This recall affects 16 lots with dosage strengths ranging from 0.125 mg to 2 mg, with expiration dates spanning August 2026 and February 2027.

This expansion follows the initial recall in July triggered by an “error at a third-party packager” where some cartons mislabeled the 0.25 mg strength as 0.125 mg.

Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling https://t.co/6oqclPQZOT pic.twitter.com/f3OJATXeCL

— U.S. FDA Recalls (@FDArecalls) November 19, 2024

Risks and Recommendations

Clonazepam is a benzodiazepine used primarily for treating panic disorders and some types of seizures. The mislabeling could inadvertently lead consumers to ingest a higher dose than intended, which might trigger drowsiness, confusion, dizziness, and more critical symptoms like loss of muscle control and severe breathing issues.

Consumers are urged to immediately stop consuming these tablets and consult their healthcare providers if they suspect an incorrect dose was taken. Retailers have been advised against selling these products to prevent any potential harm.

RECALL OF KLONOPIN! Mislabeling? Endo error? FDA? Who knows, but read and be aware. "Endo USA Inc. is recalling one lot of clonazepam disintegrating tablets because of mislabeled strength information." Talk to your Dr if you are on this specific med: https://t.co/35eqjttoT6

— Douglas Kalman PhD (@dougkalmanphdrd) July 23, 2024

No Reported Adverse Reactions

Despite the severity of potential consequences, there have not been any adverse reactions reported since the recall was announced. However, Endo Pharmaceuticals is taking precautions to ensure consumer safety.

Should consumers have any questions about the recall, Endo Pharmaceuticals has provided contact options: call (855) 589-1869 or email [email protected].

The recalled cartons list Par Pharmaceutical of New York as the distributor, emphasizing the importance of staying vigilant when handling potentially mislabeled medications.