Nerve Pain, Seizure Drug Recalled

The Harvard Drug Group is pulling 3984 cartons of gabapentin tablets after a foreign tablet was found in a carton, according to the May 17, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects gabapentin tablets, 600 mg, packaged in 100-tablet cartons (10 blister packs containing 10 tablets each, NDC 0904-6823-61), from lot T04468 (Exp 10/24). The cartons were distributed by Aurobindo Pharma USA, East Windsor, New Jersey, and Major Pharmaceuticals, Livonia, Michigan, throughout the United States.

The Harvard Drug Group voluntarily initiated the recall April 24, 2023. The FDA designated the recall Class III on May 10, 2023. The classification suggests use of the recalled product is not likely to cause harm.

Gabapentin is a prescription gamma aminobutyric acid (GABA) analogue indicated for the management of postherpetic neuralgia in adults and as adjunctive therapy in the treatment of partial onset seizure in adults and pediatric patients 3 years and older with epilepsy.