October 16, 2020
VistaPharm Inc. is recalling a single lot of nystatin oral suspension after samples tested out of specification for impurities, according to the October 14, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects nystatin oral suspension, 100,000 units per mL, bubblegum flavor, 16 fluid ounces (480 mL; NDC 66689-008-16), from lot 638800 (Exp. 10/21). The bottles were distributed throughout the United States, including Puerto Rico.
VistaPharm initiated the voluntary recall September 25, 2020. The FDA designated the recall Class III on October 5, 2020, suggesting use of the recalled medication is not likely to cause harm.
Nystatin is a prescription medicine indicated for the treatment of candidiasis in the mouth.