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.
What this means for you
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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