CLASS III Drug recall · Reported 9 Nov 2022 · FDA Enforcement Report
Susvimo (ranibizumab injection), 100mg/mL recalled by Genentech
Genentech is recalling Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One, distributed nationwide in the US. The recall was initiated on 18 Oct 2022 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-0025-2023
- FDA event ID
- 90959
- Recalling firm
- Genentech, South San Francisco, CA
- Brand
- Susvimo
- Manufacturer
- Genentech, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Oct 2022
- FDA classified
- 1 Nov 2022
- Reported
- 9 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Oct 2022 | Recall initiated by company | |
| 1 Nov 2022 | Classified by FDA | +14 days |
| 9 Nov 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot/Exp: a) 3499188, Exp 10/31/2022; Lot 3523071, Exp 6/30/2023; b) 3456735, Exp 10/23/2026; 3456737; Exp 10/29/2026; 3477671, Exp 10/31/2026; 3480781, Exp 12/19/2026; 3506526, Exp 02/25/2027; 3506531, Exp 04/15/2027
Where was it sold?
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 26 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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|---|---|---|---|---|---|
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