CLASS III Drug recall · Reported 5 May 2021 · FDA Enforcement Report
Evrysdi (risdiplam) for oral solution recalled by Genentech
Genentech is recalling Evrysdi (risdiplam) for oral solution, 60 mg/ 75mg/mL) total volume after constitution, distributed nationwide in the US. The recall was initiated on 20 Apr 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0357-2021
- FDA event ID
- 87724
- Recalling firm
- Genentech, South San Francisco, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Apr 2021
- FDA classified
- 29 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 20 Apr 2021 | Recall initiated by company | |
| 29 Apr 2021 | Classified by FDA | +9 days |
| 5 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Product as listed by the FDA
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
Where it was distributed
Distributed Nationwide in the USA.
Questions about this recall
Is Evrysdi (risdiplam) for oral solution, 60 mg/ 75mg/mL) total volume after constitution recalled?
Yes. Genentech recalled Evrysdi (risdiplam) for oral solution, 60 mg/ 75mg/mL) total volume after constitution on 20 Apr 2021. The recall is Class III and its status is Terminated. Recall number D-0357-2021.
Why was it recalled?
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Which lots are affected?
Lot #: B1001B05; B1001B08, Exp. Feb-2022
Where was it sold?
Distributed Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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