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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medical Devices/Implants & Prosthetics

Genentech Susvimo (Ranibizumab Injection) Recalled for Defective Implants

Agency Publication Date: November 1, 2022
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Summary

Genentech Inc. is recalling Susvimo (ranibizumab injection) 100mg/mL and its ocular implant delivery system because the commercial implants do not meet manufacturing specifications. This recall affects 452 vials and implants. A few patients have already reported issues with the implants that render them non-functioning, meaning the medication cannot be delivered as intended. If you are a healthcare provider using these systems, you should stop using the recalled lots immediately and return them to the manufacturer.

Risk

The ocular implants are defective and may fail to function correctly. This prevents the medication from being properly administered to the patient's eye. Several reports indicate patients have experienced non-functioning implants in clinical use.

What You Should Do

  1. This recall affects Susvimo (ranibizumab injection) 100mg/mL cartons (NDC 50242-078-55) and Susvimo Ocular Implant with Insertion Tool Assembly cartons (GTIN 00810042590014).
  2. Identify affected products by checking the lot numbers and expiration dates on the packaging. The affected lot numbers for the vials are 3499188 and 3523071. Affected lot numbers for the ocular implants are 3456735, 3456737, 3477671, 3480781, 3506526, and 3506531.
  3. Stop using the recalled product immediately and secure any remaining inventory in your facility.
  4. Contact Genentech Inc. or your authorized distributor to arrange for the return of the recalled vials and implants.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further information or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Susvimo (ranibizumab injection) 100mg/mL
Variants: 100mg/mL, Single-dose vial, Initial fill needle
Lot Numbers:
3499188 (Exp 10/31/2022)
3523071 (Exp 6/30/2023)
NDC:
50242-078-55

Sold as a carton containing one single-dose vial and one initial fill needle.

Product: Susvimo Ocular Implant with Insertion Tool Assembly
Variants: Carrier with implant, Insertion tool
Lot Numbers:
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)
UDI:
81004259001
GTIN:
00810042590014

Sold as a carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90959
Status: Resolved
Manufacturer: Genentech Inc
Sold By: hospitals; specialty pharmacies; ophthalmology clinics
Manufactured In: United States
Units Affected: 452 vials and implants
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.