Granix — Class II drug recall D-0218-2025
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2025-02-12, distributed nationwide. Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the sp
| Recall number | D-0218-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2025-01-10 |
| Classified | 2025-02-04 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 34,636 cartons |
| Reason classes | specification failure |
| NDC | 63459-0910, 63459-0910-01, 63459-0910-11, 63459-0910-12, 63459-0910-15, 63459-0910-17, 63459-0910-18, 63459-0910-36, 63459-0912, 63459-0912-01, 63459-0912-11, 63459-0912-12, 63459-0912-15, 63459-0912-17, 63459-0912-18, 63459-0912-36, 63459-0918, 63459-0918-53, 63459-0918-59, 63459-0920, 63459-0920-53, 63459-0920-59 |
| Lot numbers | 135738, 137148, 137149 |
| Expiration dates | 2025-09-30 |
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 for recall
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0218-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.