Antifungal Recalled

VistaPharm Inc. is recalling several lots of nystatin oral suspension due to a product impurity, according to the July 15, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following products, which were distributed in the United States, including Puerto Rico:

• nystatin oral suspension, 500,000 units per 5-mL cup (NDC 66689-037-50, individual cup NDC 66689-037-01, NDC 66689-037-99), from lots 619800 (Exp. 12/31/20), 626200 (Exp. 1/31/21), 619800X (Exp. 12/31/20), and 626200X (Exp. 1/31/21); and
• nystatin oral suspension, 100,000 units per mL, bubblegum flavored, 16-fluid-ounce bottle (NDC 66689-008-16), from lot 639000 (Exp. 10/31/21).

The voluntary recall was initiated by VistaPharm on June 23, 2020. The FDA designated the recall Class III on July 8, 2020. Under the recall classification, use of the affected product is not likely to cause harm. 

Nystatin is a prescription antifungal medicine used to treat yeast infections in the mouth or stomach.

—Jolynn Tumolo