Genentech Inc
FDA Regulatory Profile
Genentech Inc has 11 FDA recalls (2 Class I), 45 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0509-2024 · Class II · May 20, 2024
- Latest inspection
- May 15, 2026 · NAI
Newer recall under related name Foundation Medicine: Jun 10, 2026, Z-2951-2026.
Part of the Roche corporate family.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 11 (2 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 45 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0509-2024 | Class II | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC… | May 20, 2024 |
| D-0025-2023 | Class III | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo… | Oct 18, 2022 |
| D-0650-2021 | Class II | Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use… | Jun 9, 2021 |
| D-0357-2021 | Class III | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after… | Apr 20, 2021 |
| D-0416-2018 | Class III | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by… | Feb 5, 2018 |
| D-1175-2017 | Class I | Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml… | Sep 5, 2017 |
| D-0648-2017 | Class II | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by… | Mar 13, 2017 |
| D-097-2013 | Class III | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton… | Sep 27, 2012 |
| D-088-2013 | Class II | Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San… | Sep 20, 2012 |
| D-087-2013 | Class II | Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San… | Sep 20, 2012 |
| D-135-2013 | Class I | Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial… | Jul 30, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 15, 2026 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Apr 7, 2026 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Apr 21, 2025 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Aug 16, 2024 | Oceanside, CA | Drugs | No Action Indicated (NAI) | 3006129086 |
| May 2, 2024 | South San Francisco, CA | Drugs | Voluntary Action Indicated (VAI) | 2917293 |
| Apr 19, 2024 | Hillsboro, OR | Drugs | Voluntary Action Indicated (VAI) | 3007232634 |
| Mar 20, 2024 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Mar 12, 2024 | South San Francisco, CA | Drugs | Voluntary Action Indicated (VAI) | 2917293 |
| Aug 11, 2023 | South San Francisco, CA | Drugs | Voluntary Action Indicated (VAI) | 2917293 |
| Feb 21, 2023 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Oct 7, 2022 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Apr 2, 2019 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Jul 5, 2018 | Hillsboro, OR | Drugs | Voluntary Action Indicated (VAI) | 3007232634 |
| Oct 18, 2017 | Oceanside, CA | Drugs | Voluntary Action Indicated (VAI) | 3006129086 |
| Aug 3, 2017 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Jul 12, 2017 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Feb 1, 2017 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Sep 16, 2016 | South San Francisco, CA | Drugs | No Action Indicated (NAI) | 2917293 |
| Jul 8, 2016 | South San Francisco, CA | Veterinary | No Action Indicated (NAI) | 2917293 |
| Apr 15, 2016 | Hillsboro, OR | Drugs | Voluntary Action Indicated (VAI) | 3007232634 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.