Tablets Recalled Over Label Error

AvKARE Inc is recalling 8328 bottles of lamotrigine tablets. The August 17, 2022, US Food and Drug Administration (FDA) Enforcement Report cited a “label error on declared strength” but provided no further details about the error.

The recall affects lamotrigine tablets, 100 mg, 1000-count bottles (NDC 42291-367-10, UPC 3 42291 36710 4), from lots 42581 (Exp. 12/24), 42484 (Exp. 11/24), 41204 (Exp. 5/24), 38723 (Exp. 2/23), and 37623 (Exp. 10/22). The tablets were manufactured for AvKARE, Pulaski, TN, and distributed throughout the United States.

AvKARE voluntarily initiated the recall July 20, 2022. On August 8, 2022, the FDA designated the recall Class III. According to the recall classification, use of the affected tablets is not likely to cause harm.

Lamotrigine is a prescription anticonvulsant used to treat epilepsy and bipolar disorder.