Benzodiazepine Recalled

Potential cross-contamination with the antipsychotic clozapine has led Sun Pharmaceutical Industries Inc. to recall a single lot of clonazepam tablets. According to the August 5, 2020, US Food and Drug Administration (FDA) Enforcement Report, samples from the lot tested out of specification for an unknown impurity, which was later identified as clozapine, during routine testing.

The recall affects 60-count bottles of clonazepam orally disintegrating tablets, 0.125 mg (NDC 57664-783-86), from lot AA84106 (Exp. 9/21). The affected tablets were distributed throughout the United States. 

Sun Pharmaceutical Industries voluntarily initiated the recall July 6, 2020. On July 30, 2020, the FDA designated the recall Class III, suggesting use of the recalled tablets is not likely to cause harm. 

Clonazepam is a prescription benzodiazepine used to treat seizures and panic disorders.

—Jolynn Tumolo