Genentech Recalls Evrysdi Due to Leaking Child-Resistant Packaging Defects
Genentech is recalling Evrysdi prescription bottles that may leak due to a fit issue, posing a risk of drug exposure through skin or eye contact.
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (drug exposure via skin/eye and child access) where injury has not yet been reported, aligning with the High severity criteria.
Plain-English summary
Genentech, a member of the Roche Group, is recalling approximately 14,000 bottles of Evrysdi (risdiplam), a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. The recall involves 100 mL amber bottles labeled with "Evrysdi (risdiplam) for oral solution" and NDC 20242-175-07. These bottles were sold at select specialty pharmacies nationwide as a prescribed medicine from August 2020 through the present.
The recall is due to a fit issue between the press-in bottle adapter and the bottleneck, which can cause the bottles to leak. If a bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Additionally, the packaging failure means the bottles do not meet child-resistant packaging requirements under the Poison Prevention Packaging Act (PPPA). Genentech has received 26 reports of leaking bottles, but no injuries have been reported.
Consumers should immediately store Evrysdi in a safe location out of reach and sight of children and inspect the bottle for any leaking. If the bottle is leaking, consumers should contact Genentech for a free replacement. The leakage is not anticipated to impact the safety or efficacy of the administered medicine. If Evrysdi gets on skin, wash the area with soap and water; if it gets in eyes, rinse with water. Genentech is contacting all known purchasers directly.
The recalled product
- Product
- Evrysdi™ (risdiplam)
- Category
- Drug — Prescription Medication
- Affected units
- 14,000
Distribution
Distributed nationwide across the United States.
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