Genentech, Inc.

• EmicizumabHemlibra · 6 products
• TocilizumabTyenne, Tofidence, Actemra · 5 products
• Baloxavir marboxilXofluza · 5 products
• Mycophenolate mofetilCellcept, Myhibbin · 4 products
• MosunetuzumabLunsumio, Lunsumio Velo · 4 products
• OmalizumabOmlyclo, Xolair, Xolair Pfs · 4 products
• Oseltamivir phosphateTamiflu · 3 products
• Ranibizumab-eqrnCimerli, Byooviz, Nufymco · 3 products
• EntrectinibRozlytrek · 3 products
• GlofitamabColumvi · 2 products
• AtezolizumabTecentriq · 2 products
• Ado-trastuzumab emtansineKadcyla · 2 products
• Polatuzumab vedotinPolivy · 2 products
• Rituximab and hyaluronidaseRituxan Hycela · 2 products
• Bevacizumab-bvzrZirabev, Jobevne, Vegzelma · 2 products
• InavolisibItovebi · 2 products
• RisdiplamEvrysdi · 2 products
• Pertuzumab, trastuzumab, and hyaluronidase-zzxfPhesgo · 2 products
• SatralizumabEnspryng · 2 products
• Rituximab-arrxRiabni, Ruxience, Truxima · 2 products
• PirfenidoneEsbriet · 2 products
• Trastuzumab and hyaluronidase-oyskHerceptin Hylecta · 1 product
• CrovalimabPiasky · 1 product
• Alectinib hydrochlorideAlecensa · 1 product
• Ocrelizumab and hyaluronidaseOcrevus Zunovo · 1 product
• VemurafenibZelboraf · 1 product
• Dornase alfaPulmozyme · 1 product
• Atezolizumab and hyaluronidase-tqjsTecentriq Hybreza · 1 product
• OcrelizumabOcrevus · 1 product
• AlteplaseCathflo Activase · 1 product
• PertuzumabPerjeta · 1 product
• CobimetinibCotellic · 1 product
• VismodegibErivedge · 1 product
• TrastuzumabOgivri, Kanjinti, Herzuma · 1 product
• ObinutuzumabGazyva · 1 product
• FaricimabVabysmo · 1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2025

1. July 30, 2025 · Class II · Ongoing · D-0571-2025 · Omalizumab

   CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

   Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

2. July 30, 2025 · Class II · Ongoing · D-0572-2025 · Omalizumab

   CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

   Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

2024

1. May 20, 2024 · Class II · Terminated · D-0509-2024 · Alteplase

   Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

   Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

2022

1. October 18, 2022 · Class III · Terminated · D-0025-2023 · Ranibizumab-eqrn

   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.

   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

2021

1. June 9, 2021 · Class II · Terminated · D-0650-2021 · Omalizumab

   Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.

   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

2. April 20, 2021 · Class III · Terminated · D-0357-2021 · Risdiplam

   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.

   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

3. March 15, 2021 · Class II · Terminated · D-0476-2021 · Alteplase

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech

2017

1. March 13, 2017 · Class II · Terminated · D-0648-2017 · Cobimetinib

   Superpotent Drug: An oversized tablet was found in a bottle.

   Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.

2012

1. September 27, 2012 · Class III · Terminated · D-097-2013 · Mycophenolate mofetil

   Short Fill: some bottles contained less than 120-count per labeled claim.

   CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, I

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1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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