Medications & Supplements/Prescription Drugs

Granix (tbo-filgrastim) Injection Recalled for Failed Stability Specifications

Agency Publication Date: February 4, 2025

Summary

Teva Pharmaceuticals USA, Inc. has recalled 34,636 cartons of Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL. The recall was issued after 12-month stability testing revealed that a specific peptide in the medication fell below required levels. This failure to meet stability specifications may impact the potency or effectiveness of the drug. Consumers using this prescription medication should consult their healthcare provider or pharmacist regarding their treatment.

Risk

The stability failure means the medication may not contain the intended amount of active ingredients, potentially making it less effective in treating the patient's condition. No injuries or adverse reactions have been reported in connection with this recall.

What You Should Do

This recall involves Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL prefilled syringes, distributed in cartons containing either one or ten syringes.
Identify affected products by looking for lot numbers 135738, 137149, or 137148, all of which have an expiration date of 09/30/2025.
Check the medication packaging for the following National Drug Codes (NDC): 63459-910-11, 63459-910-15, 63459-910-17, or 63459-910-12 (on the syringe blister).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

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

Variants: 300 mcg/0.5 mL, Single Dose prefilled syringe, 1 syringe per carton, 10 syringes per carton

Lot Numbers:

135738 (Exp 09/30/2025)

137149 (Exp 09/30/2025)

137148 (Exp 09/30/2025)

NDC:

63459-910-11

63459-910-12

63459-910-15

63459-910-17

Manufactured by UAB Teva Baltics in Vilnius, Lithuania; distributed by Teva Pharmaceuticals USA, Inc. Includes variants with and without safety guards.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96115

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies; Hospitals; Authorized Drug Distributors

Manufactured In: Lithuania, Israel

Units Affected: 34,636 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL prefilled syringes, distributed in cartons containing either one or ten syringes.

Identify affected products by looking for lot numbers 135738, 137149, or 137148, all of which have an expiration date of 09/30/2025.

Check the medication packaging for the following National Drug Codes (NDC): 63459-910-11, 63459-910-15, 63459-910-17, or 63459-910-12 (on the syringe blister).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

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

Variants: 300 mcg/0.5 mL, Single Dose prefilled syringe, 1 syringe per carton, 10 syringes per carton

Lot Numbers:

135738 (Exp 09/30/2025)

137149 (Exp 09/30/2025)

137148 (Exp 09/30/2025)

NDC:

63459-910-11

63459-910-12

63459-910-15

63459-910-17

Manufactured by UAB Teva Baltics in Vilnius, Lithuania; distributed by Teva Pharmaceuticals USA, Inc. Includes variants with and without safety guards.