The Recall Desk

Manufacturer

Genentech, Inc.

11 recalls in our database name Genentech, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
3
Most recent
2024-06-05

Of the 11 recalls from Genentech, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (27%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • HighFDA (Drugs)·D-0509-2024·2024-06-05

    Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers

    Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.

    Product
    CATHFLO ACTIVASE — CATHFLO ACTIVASE (ALTEPLASE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2023·2022-11-09

    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.

    Product
    SUSVIMO — SUSVIMO (RANIBIZUMAB)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2021·2021-07-14

    Genentech Xolair Injection Recalled for Failed Stability Specifications

    Genentech is recalling two lots of Xolair (omalizumab) injection nationwide due to out-of-specification Polysorbate 20 content detected at the 12-month stability testing timepoint. The affected lots are 3352758 and 3352759, both with August 2021 expiration dates.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0357-2021·2021-05-05

    Genentech Recalls Evrysdi Oral Solution Due to Defective Bottle Adapters

    Genentech is recalling 2,627 bottles of Evrysdi (risdiplam) for oral solution because some have incorrect press-in-bottle-adapters that do not fit co-packed syringes.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0416-2018·2018-02-21

    Genentech Recalls Klonopin Tablets Due to Missing Schedule IV Labeling

    Genentech is recalling Klonopin (clonazepam) 0.5 mg tablets because the Schedule IV controlled substance indicator was omitted from the product carton.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1175-2017·2017-09-27

    Genentech Recalls Activase Due to Cracked Sterile Water Vials

    Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.

    Product
    Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0648-2017·2017-04-12

    Genentech Recalls Cotellic Tablets Due to Oversized Tablet Discovery

    Genentech is recalling 748 bottles of Cotellic (cobimetinib) tablets because an oversized tablet was found in a bottle. The affected product was distributed in New Jersey and Illinois.

    Product
    COTELLIC — COTELLIC (COBIMETINIB)
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-135-2013·2013-01-30

    Genentech Recalls Trastuzumab Kits Due to Potential Glass Particulates

    Genentech is recalling 2,140 Trastuzumab Kits for investigational use because the included Bacteriostatic Water for Injection diluent vials may contain glass particulates.

    Product
    Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reco
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-097-2013·2012-12-26

    Genentech Recalls CellCept Capsules Due to Short Fill Issues

    Genentech is recalling 1,128 bottles of CellCept (mycophenolate mofetil) 250 mg capsules because some bottles contained fewer than 120 capsules as labeled.

    Product
    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, Inc., South San Francisco, CA 94080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-088-2013·2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 10 Due to Defective Delivery System

    Genentech is recalling 12,791 syringes of Nutropin AQ NuSpin 10 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-087-2013·2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 20 Due to Defective Delivery System

    Genentech is recalling 10,306 syringes of Nutropin AQ NuSpin 20 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Genentech

biotech company

Country
United States
Founded
1976
Parent company
Hoffmann-La Roche

Official website

Source: Wikidata (Q899140), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.