Evrysdi — Class III drug recall D-0357-2021
Terminated recall by Genentech Inc, reported 2021-05-05, distributed nationwide. Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorre
| Recall number | D-0357-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech Inc, South San Francisco, CA, United States |
| Recall initiated | 2021-04-20 |
| Classified | 2021-04-29 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2022-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,627 bottles |
| Reason classes | packaging |
| NDC | 50242-0175-05 |
| Lot numbers | B1001B05, B1001B08, FEB-2022 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0357-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.