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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Genentech Inc: Evrysdi (risdiplam) Recalled Due to Defective Bottle Adapters

Agency Publication Date: April 27, 2021
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Summary

Genentech Inc. has recalled 2,627 bottles of Evrysdi (risdiplam) for oral solution (60 mg/80mL). The recall was initiated because some bottles were packaged with incorrect press-in-bottle-adapters (PIBA) that have a female fitting instead of the required male fitting. This defect prevents the adapter from connecting properly with the co-packed syringes, making it difficult or impossible to administer the medication correctly. Consumers should contact their healthcare provider or pharmacist for guidance on obtaining a functional replacement or adapter.

Risk

The incorrect adapter fit prevents the medication from being drawn into the co-packed syringe. This could lead to a delay in treatment or incorrect dosing for patients relying on this prescription medication.

What You Should Do

  1. Locate your Evrysdi (risdiplam) for oral solution bottle (60 mg/80mL, 0.75mg/mL) and check the packaging for NDC 50242-175-05.
  2. Check the lot number and expiration date printed on the bottle label to see if it matches Lot B1001B05 or Lot B1001B08 with an expiration date of Feb-2022.
  3. Inspect the press-in-bottle-adapter (PIBA) to see if it has a female fit that prevents it from connecting to the syringes provided in the kit.
  4. Contact your healthcare provider or pharmacist immediately to discuss how to continue your treatment and to report the defective container.
  5. Return any unused or defective product to your pharmacy for a refund and contact Genentech for further instructions regarding replacement parts.
  6. For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL)
Model:
NDC:50242-175-05
Lot Numbers:
B1001B05 (Exp. Feb-2022)
B1001B08 (Exp. Feb-2022)
Date Ranges: Feb-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87724
Status: Resolved
Manufacturer: Genentech Inc
Manufactured In: United States
Units Affected: 2,627 bottles
Distributed To: Nationwide
Agency Last Updated: April 29, 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.

Find an Attorney

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: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.