FDA: Common Anxiety Drug Being Recalled Over ‘Possibly Life-Threatening’ Mislabeling

The Food and Drug Administration building, in this file photo. Sarah Silbiger/Getty Images

A pharmaceutical company expanded its prior recall of anti-anxiety drug clonazepam tablets due to a potential “mislabeling” about the product’s strength on its carton that could be “life-threatening,” according to an announcement published by the U.S. Food and Drug Administration (FDA).

In the notice updated Nov. 19, Endo Inc. said that the impacted products, already under recall, are Clonazepam Orally Disintegrating Tablets, USP.

An ongoing investigation initiated by the firm shows there is a chance more impacted product lots “contain a limited number of cartons printed with the incorrect strength” and incorrect National Drug Code because of “an error by a third-party packager,” it said.

The clonazepam was packaged by Par Pharmaceutical before the drug was acquired by Endo, according to the notice.

“Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” said the notice.

“There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.”

But so far, the company said it has not received any reports of adverse reactions from the recalled drugs.

The recalled Endo-made clonazepam lots contain 60 tablets packed into 10 blister strips that each contain 6 tablets. The blister strip pocket and carton also have the name, lot number, strength, NDC number, and expiration date printed.

Endo said that the recalled lots were distributed through wholesale distributors to retail pharmacies around the United States, and the company is providing notices to the retailers and wholesalers that received the impacted lots.

Wholesalers and pharmacies should immediately stop distributing and dispensing the product, it said. Consumers, meanwhile, are urged to discontinue using the recalled product.

“In the event that a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician,” the notice said.

A benzodiazepine like Xanax or Valium, clonazepam is used to treat anxiety, seizure, obsessive-compulsive disorder, and panic disorders. The drug, which slows down brain activity and causes sedation or calming effects, is sold under the brand name Klonopin and others.

In many areas of the world and in the United States, the drug is commonly used recreationally.

Clonazepam is ranked as the 57th most commonly prescribed medication in the United States, with more than 11.7 million estimated prescriptions being filled out in 2022, according to ClinCalc, a database that tracks medications.

According to the FDA announcement, the products under recall and their NDC numbers are as follows.

• Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02
• Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02
• Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02
• Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02

A full list of the impacted products, lot numbers, strength, and other information can be accessed via the FDA’s website.

Symptoms of Overdose

Health officials say that symptoms of a clonazepam overdose can include a change or loss in consciousness, changes in speech patterns, lack of coordination, hallucinations, mood or mental changes, weakness, muscle pain, sleepiness or drowsiness that can be considered unusual, shakiness, unsteadiness, and nightmares, according to the Mayo Clinic’s website.

Other symptoms can include problems with muscle control or coordination, restlessness, irritability, unusual excitement, and nervousness, according to the clinic.