Bipolar Drug Recalled

Sigmapharm Laboratories is voluntarily recalling 15,052 bottles of asenapine sublingual tablets because they were manufactured using cherry flavoring instead of black cherry flavoring, according to the May 26, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following products, which were distributed throughout the United States:

• asenapine sublingual tablets, 5 mg, 60-count bottles (NDC 42794-016-10), from lots 2012501, 2012601, 2012701, and 2100701 (Exp. 8/22); and
• asenapine sublingual tablets, 10 mg, 60-count bottles (NDC 42794-017-10), from lots 2012801, 2012901, 2013001, and 2100501 (Exp. 8/22), and 2100101 (Exp. 11/22).

Sigmapharm Laboratories initiated the recall April 19, 2021. The FDA designated the recall Class III on May 14, 2021, communicating use of the recalled tablets is not likely to cause harm. 

Asenapine sublingual tablets are indicated for the treatment of people with bipolar disorder.