FDA Drug recall D-0218-2025
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, Bl…
- FDA Drug
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of 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, Bl… by Teva Pharmaceuticals Usa, citing failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0218-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-10 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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.
Reason
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Identifiers
| ndc | 63459-910-01 |
|---|---|
| ndc | 63459-910-12 |
| ndc | 63459-910-11 |
| ndc | 63459-910-15 |
| ndc | 63459-910-18 |
| ndc | 63459-910-17 |
| ndc | 63459-910-36 |
| ndc | 63459-912-01 |
| ndc | 63459-912-12 |
| ndc | 63459-912-11 |
| ndc | 63459-912-15 |
| ndc | 63459-912-18 |
| ndc | 63459-912-17 |
| ndc | 63459-912-36 |
| ndc | 63459-918-53 |
| ndc | 63459-918-59 |
| ndc | 63459-920-53 |
| ndc | 63459-920-59 |
| code_info | Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.