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Drug FDA Class II Ongoing Failed specifications

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

Teva Pharmaceuticals USA, Inc Published Feb 12, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Teva Pharmaceuticals USA, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Stability - Peptide Degradation · primary

Affected products (1)

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.

GRANIX · 34,636 cartons

NDC: 63459-910, 63459-912, 63459-918, 63459-920, 63459-910-01, 63459-910-12, 63459-910-11, 63459-910-15, 63459-910-18, 63459-910-17, 63459-910-36, 63459-912-01, 63459-912-12, 63459-912-11, 63459-912-15, 63459-912-18, 63459-912-17, 63459-912-36, 63459-918-53, 63459-918-59, 63459-920-53, 63459-920-59
Code info: Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 10, 2025
  2. Published
    Feb 12, 2025
Recall number
D-0218-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.