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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing/stability issue (out-of-specification ingredient content) with no reported illnesses or injuries. The hazard is a potential quality defect rather than an active safety threat, consistent with a Moderate severity classification.
Plain-English summary
Genentech Inc. is recalling 88,620 prefilled syringes of Xolair (omalizumab) Injection, 150 mg/1 mL, distributed nationwide. The recall was initiated due to failed stability specifications: out-of-specification results for Polysorbate 20 (PS20) content were detected at the 12-month testing time point.
The affected product is identified as: Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, single-dose, for subcutaneous use. Lot numbers 3352758 and 3352759, both with August 2021 expiration dates, are subject to this recall. The product was manufactured by Genentech, Inc., South San Francisco, CA.
Consumers and healthcare providers who have this product should discontinue use and contact Genentech for further instructions regarding return or disposal. The source text does not provide information on reported adverse events or illnesses associated with this lot.
The recalled product
- Product
- XOLAIR (OMALIZUMAB)
- Brand
- XOLAIR
- Manufacturer
- Genentech Inc
- Hazard
- stability-specification-failure
- ingredient-specification-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot No.: 3352758
- Exp. Date Aug 2021
- Lot No.: 3352759
Distribution
Distributed nationwide across the United States.
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