Product Wiki · Recalls · U.S. CPSC

Recall 21729 — Evrysdi™ (risdiplam)

U.S. CPSC · United States · 2021-03-18

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Agency
U.S. CPSC
Recall identifier
21729
Date of alert
2021-03-18
Country / jurisdiction
United States
Risk type
recall
Brand
Genentech, a member of the Roche Group, of South San Francisco, Calif.
Product category
consumer_product
Reported risk: This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. The recalled 100 mL amber bottles have "Evrysdi (risdiplam) for oral solution," the dosage and "NDC 20242-175-07" on the front of the bottle labels. Hazards: The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
Primary source: https://www.cpsc.gov/Recalls/2021/Genentech-Recalls-Prescription-Drug-Evrysdi-Du

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.