Ranibizumab eye implant recalled for non-functioning delivery system
Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall of defective drug delivery implants with documented non-functioning units affecting a few patients. No illnesses or injuries have been reported. This fits the typical profile of a low-risk Class III recall.
Plain-English summary
Genentech Inc. is recalling Susvimo (ranibizumab injection, 100 mg/mL), an ocular implant distributed nationwide. The implant is designed to deliver anti-VEGF therapy directly into the eye for serious eye conditions. The recall involves 452 vials and implants with multiple lot numbers and expiration dates through April 2027.
The implants have a manufacturing defect affecting the delivery system that does not meet filed specifications. A few patients have experienced implants that do not function properly and fail to deliver medication as intended.
Patients who have received a Susvimo implant should contact their healthcare provider to determine whether they received a recalled unit and to discuss treatment options.
The recalled product
- Product
- SUSVIMO (RANIBIZUMAB)
- Brand
- SUSVIMO
- Manufacturer
- Genentech Inc
- Affected units
- 452
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distribution
Distributed nationwide across the United States.
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