Susvimo — Class III drug recall D-0025-2023
Terminated recall by Genentech Inc, reported 2022-11-09, distributed nationwide. Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few
| Recall number | D-0025-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech Inc, South San Francisco, CA, United States |
| Recall initiated | 2022-10-18 |
| Classified | 2022-11-01 |
| Reported by FDA | 2022-11-09 |
| Terminated | 2024-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 452 vials |
| UPC / GTIN / UDI-DI | 00810042590014 |
| NDC | 50242-0078, 50242-0078-12, 50242-0078-55 |
| Lot numbers | 3523071 |
| Expiration dates | 2022-10-31, 2023-06-30, 2026-10-23, 2026-10-29, 2026-10-31, 2026-12-19, 2027-02-25, 2027-04-15 |
Product
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
Reason for recall
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
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-0025-2023. 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.