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
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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