FDA Drug recall D-0650-2021

Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use

• FDA Drug
• Class II
• terminated
• Published 2021-07-14

On 2021-07-14 the FDA classified a Class II recall of Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use by Genentech, citing failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.

Read the official FDA Drug notice

Product

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 Francisco, CA 9480-4990. NDC: 50242-215-01

Reason

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Other recalls by Genentech

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  FDA Drug · Class II · 2024-06-05 · Genentech
• Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill…
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• Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, I…
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• Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only
  FDA Drug · Class III · 2018-02-21 · Genentech
• 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

All Genentech recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.