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Spinal Muscular Atrophy Drug Recalled

05/06/2021

Defective containers have prompted Genentech Inc. to voluntarily recall 2627 bottles of Evrysdi (risdiplam). According to the May 5, 2021, US Food and Drug Administration (FDA) Enforcement Report, customers have reported incorrect press-in-bottle-adapters that cannot be used with the copackaged syringes. 

The recall affects Evrysdi, 60 mg/80 mL (0.75 mg/mL), 80-mL total volume after constitution (NDC 50242-175-05), from lots B1001B05 and B1001B08 (Exp. 2/22). The drug was distributed throughout the United States by Genentech. 

Genentech voluntarily initiated the recall April 20, 2021. The FDA designated the recall Class III on April 29, 2021. Under the recall classification, use of the affected product is not likely to cause harm. 

Evrysdi is a prescription drug used to treat spinal muscular atrophy.

—Jolynn Tumolo

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