Genentech recalls

Genentech appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2024-06-05.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
  FDA Drug · Class II · 2024-06-05 · Genentech
  Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
• Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill…
  FDA Drug · Class III · 2022-11-09 · Genentech
  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.
• Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use
  FDA Drug · Class II · 2021-07-14 · Genentech
  Reason: Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
• Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, I…
  FDA Drug · Class III · 2021-05-05 · Genentech
  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.
• Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only
  FDA Drug · Class III · 2018-02-21 · Genentech
  Reason: Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
• Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP a…
  FDA Drug · Class I · 2017-09-27 · Genentech
  Reason: Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
• Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland
  FDA Drug · Class II · 2017-04-12 · Genentech
  Reason: Superpotent Drug: An oversized tablet was found in a bottle.
• Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg)
  FDA Drug · Class I · 2013-01-30 · Genentech
  Reason: Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
• CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05
  FDA Drug · Class III · 2012-12-26 · Genentech
  Reason: Short Fill: some bottles contained less than 120-count per labeled claim.
• Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
  FDA Drug · Class II · 2012-12-12 · Genentech
  Reason: Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
• Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
  FDA Drug · Class II · 2012-12-12 · Genentech
  Reason: Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).