Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Granix (tbo-filgrastim)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDCs
63459-0910-11
63459-0910-12
63459-0910-15
63459-0910-17
Compare with the code on your package — it is the most precise check available.
Drug: Filgrastim
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Granix tbo-filgrastim NDC 63459-0910 |
FILGRASTIM 300 ug/.5mL | Injection, Solution Subcutaneous |
Cephalon, LLC | Rx |
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- NDC code
- 63459-910-11
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0218-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Filgrastim recalls
See all
Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Other recalls by Teva Pharmaceuticals USA, Inc
All 2025 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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