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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskCPSC
Medications & Supplements/Prescription Drugs

Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)

Agency Publication Date: March 18, 2021
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Summary

Genentech has recalled approximately 14,000 units of Evrysdi (risdiplam) for oral solution because a fit issue between the bottle adapter and the bottleneck can cause the bottles to leak. The recalled product is an amber-colored 100 mL bottle identified by the NDC number 20242-175-07, and it was sold through select specialty pharmacies nationwide starting in August 2020. If your bottle is leaking, you should contact Genentech for a free replacement as described in the Your Remedy Options section.

Risk

The leak poses a risk of drug exposure if the liquid contacts the skin or eyes; additionally, the product fails to meet mandatory child-resistant packaging requirements under the Poison Prevention Packaging Act. Genentech has received 26 reports of leaking bottles, though no injuries have been reported.

What You Should Do

  1. Immediately store the Evrysdi bottle in a safe location out of reach and sight of children.
  2. Inspect your bottle for any signs of leaking.
  3. If you identify a leak, follow these instructions: 'Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.'
  4. For questions or to coordinate a replacement, contact Genentech at 800-334-0290 from 8 a.m. to 8 p.m. ET Monday through Friday or visit www.Evrysdi.com and click the 'leaking bottles safety information' banner.
  5. For additional questions, contact the CPSC Hotline at 800-638-2772 or visit www.cpsc.gov.

Your Remedy Options

📋Replace

Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.

Contact: Genentech at 800-334-0290 from 8 a.m. to 8 p.m. ET Monday through Friday or online at www.Evrysdi.com and click on the "leaking bottles safety information" banner on the homepage for more information.

Affected Products

Product: Evrysdi (risdiplam) for oral solution (100 mL)
Model:
NDC 20242-175-07
Date Ranges: August 2020 through the present

Product Images

Recalled prescription drug Evrysdi

Recalled prescription drug Evrysdi

Recalled prescription drug with press-in bottle adapter

Recalled prescription drug with press-in bottle adapter

Additional Information

Agency: Consumer Product Safety Commission (CPSC)
Recall ID: 21729
Status: Active
Manufacturer: Genentech, a member of the Roche Group, of South San Francisco, Calif.
Sold By: Select specialty pharmacies nationwide as a prescribed medicine from August 2020 through the present. The price of the medication varies based on health insurance terms and other factors.
Manufactured In: Switzerland
Units Affected: About 14,000
Distributed To: Nationwide
Contact: Genentech at 800-334-0290 from 8 a.m. to 8 p.m. ET Monday through Friday or online at www.Evrysdi.com and click on the "leaking bottles safety information" banner on the homepage for more information.
Agency Last Updated: March 18, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response