Common Anxiety Medication Recalled Over "Life-Threatening" Mistake, FDA Says
A mislabeling error could lead to an unintentional overdose, with serious complications possible.
Those of us who suffer from anxiety know how debilitating it can be. The panic associated with anxiety disorders can leave you feeling irritable, not to mention the physical side effects, like a racing heart and stomachaches. To reduce anxiety, many people turn to prescription medication, but if that's you, you'll want to be aware of the latest recall. A mislabeling mistake on boxes of clonazepam could lead to "life-threatening" complications.
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On July 17, the U.S. Food and Drug Administration (FDA) shared a new announcement from the speciality pharmaceutical company Endo, Inc. According to the notice, the company's subsidiary, Endo USA, Inc., is now "voluntarily recalling" some of its clonazepam tablets.
Clonazepam is a type of benzodiazepine medication that can be "used for the treatment of anxiety, as an anticonvulsant, or for its sedative effects," according to Drugs.com. It is available generically, but is also commonly known by the brand name Klonopin.
The latest data from ClinCalc reveals that clonazepam is one of the most commonly prescribed medications in the U.S., with an estimate of over 14.1 million prescriptions filled nationwide in 2021.
If you'v been prescribed a 60-tablet carton of Clonazepam Orally Disintegrating tablets with the lot number 550147301, however, you are now being "advised to discontinue use of the product," according to the recall announcement.
As Endo explains in the notice, this specific lot is being recalled because of a mislabeling error caused by a third-party packager. Cartons of some packs of Clonazepam Orally Disintegrating tablets incorrectly list the product strength as 0.125 milligrams instead of 0.25 milligrams, which could lead to unintentional overdose.
"Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion," the company says in its 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."
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While Endo has not received any reports of adverse events associated with the mislabeling, the company is still urging consumers not to use the recalled medication, and is "arranging for the return of all existing inventory."
The recalled lot of Clonazepam Orally Disintegrating tablets was sent to retail pharmacies nationwide through various wholesale distributors.
"Retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase," Endo advises.
The medication is packaged in 60-tablet cartons that have labels featuring the product name, strength, lot number, expiration date, and National Drug Code (NDC) number. Those included in the recall should display the lot number 550147301, the expiration date Aug. 2026, and the NDC 49884-307-02.
The strength on the recalled medication packaging may be listed as 0.25 or 0.125, depending on whether it received a correct carton label or not.
"In the event that a patient inadvertently took a 0.25 mg dose rather than the intended 0.125 mg dose, they are advised to consult a physician," Endo says.
