Drug Safety Alerts

Xolair 150 mg/1 mL Prefilled Syringes Consumer-Level Recall

6/9/2021

On June 9, 2021, Genentech issued a consumer-level recall of Xolair 150 mg/1 mL prefilled syringes, NDC #50242-0215-01. This recall was issued because routine testing showed that Xolair prefilled syringes from these two lots have an expiration date period shorter than expected, and earlier than what is labeled on the box.

This recall affects lot numbers 3352758 expiration date AUG 2021, and 3352759 expiration date AUG 2021. No other lots are affected by this recall.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

Genentech is directing patients not to use recalled Xolair 150 mg/1 mL prefilled syringes, to obtain replacement product from their doctor or pharmacy, and to return recalled product.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information, please call Genentech Medical Communications at 1-800-821-8590. You may also call the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov/.