Class IIOngoing

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL recall

FDA recall D-0218-2025 · initiated Jan 10, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Details

Product: Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Product was distributed nationwide.
Initiated: Jan 10, 2025
FDA report date: Feb 12, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0218-2025 ↗

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