Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL recall
FDA recall D-0218-2025 · initiated Jan 10, 2025
Teva Pharmaceuticals USA, Inc recalled Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL in Jan 2025 — an FDA Class II recall (D-0218-2025) because Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 34,636 cartons
Details
- 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.
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed nationwide.
- Initiated
- Jan 10, 2025
- FDA report date
- Feb 12, 2025
Frequently asked
- Was Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL recalled?
- Teva Pharmaceuticals USA, Inc recalled Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL in Jan 2025 — an FDA Class II recall (D-0218-2025) because Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL recalled?
- Per the FDA enforcement record, the reason for recall D-0218-2025 was: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
- Is a recalled Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL are affected?
- Distributed: Product was distributed nationwide.. The recall covers these lots — Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0218-2025.