Drug recall: Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Sy

FDA enforcement event 88100 · Class II · initiated 9 Jun 2021 · status Terminated · terminated 11 Aug 2022

DrugVoluntary: Firm initiated1 product recordSouth San Francisco, CA

Genentech Inc (South San Francisco, CA) initiated this drug recall on 9 Jun 2021; FDA lists 1 product record under event 88100, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 299 drug enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 11 Aug 2022. Initiation: voluntary: firm initiated. Genentech Inc has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Genentech Inc, South San Francisco, CA.

Reason for recall

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

Distribution

"Product was distributed nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0650-2021	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	88,620 prefilled syringes	Class II	Terminated	14 Jul 2021

Context

60%of 2021 drug events are Class II299 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Genentech Inc

Initiated	Product (first record)	Type	Class	Records
20 May 2024	Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64	Drug	Class II	1
18 Oct 2022	Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Su	Drug	Class III	1
20 Apr 2021	Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distribut	Drug	Class III	1
5 Feb 2018	Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Mem	Drug	Class III	1
5 Sep 2017	Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water	Drug	Class I	1
13 Mar 2017	Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc.	Drug	Class II	1
27 Sep 2012	CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b	Drug	Class III	1
20 Sep 2012	Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#5024	Drug	Class II	2
30 Jul 2012	Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water	Drug	Class I	1

All 10 events for Genentech Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Product was distributed nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.