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FDA Recalls Nystatin Oral Suspension

04/11/2019

Akorn Inc. is recalling 2796 bottles of nystatin oral suspension, 100,000 units per mL, 473 mL per bottle (NDC 50383-587-16), because an unknown impurity was detected during 18-month stability testing. The recall was included in the April 10, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects bottles from lot 356527 (Exp. 3/19), which were distributed in Arkansas and Mississippi.  

Akorn voluntarily initiated the recall March 28, 2019. On April 4, 2019, the FDA designated it Class III. Under the recall classification, use of the affected product is not likely to cause harm. 

Nystatin oral suspension is available with a prescription to treat fungal infections of the mouth. 

—Jolynn Tumolo

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