South San Francisco, CA, United States
Genentech Inc recalls
5 recalls recorded since 2018, most recently on 20 May 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 20 May 2024
- Terminated
- 11 August 2025
- Reason
- Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0509-2024
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Terminated Class III Drugs
- Recall started
- 18 October 2022
- Terminated
- 17 April 2024
- Reason
- 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.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0025-2023
- 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 In
Terminated Class II Drugs
- Recall started
- 9 June 2021
- Terminated
- 11 August 2022
- Reason
- Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
- Distribution
- Product was distributed nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0650-2021
- Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Fr
Terminated Class III Drugs
- Recall started
- 20 April 2021
- Terminated
- 18 January 2022
- Reason
- Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0357-2021
- Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
Terminated Class III Drugs
- Recall started
- 5 February 2018
- Terminated
- 6 September 2018
- Reason
- Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
- Distribution
- Distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0416-2018
- Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.