Teva Granix Injection Recall: Stability Test Failure Risk
Teva Pharmaceuticals recalls Granix (tbo-filgrastim) injection due to stability test failure. This may affect medication safety. Check product details to see if you have recalled items.
Lower-risk recall
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Contact the company
What happened, in plain English
Teva Pharmaceuticals is recalling Granix (tbo-filgrastim) injections because a stability test showed one of the key peptides didn't meet quality standards. This could mean the medication might not work properly or be unsafe for patients who need it. Read more at govinfonow.com/recall/32334-teva-granix-injection-recall-stability-test-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32334-teva-granix-injection-recall-stability-test-failure-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0218-2025
Cite this page
“Teva Granix Injection Recall: Stability Test Failure Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32334-teva-granix-injection-recall-stability-test-failure-risk. Based on FDA recall #D-0218-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2025%22&limit=1).
Why it’s dangerous
The stability test for one of the key peptides in the medication fell below the required safety limits. This could mean the medication might not be effective or could pose a safety risk if stored or used incorrectly.
Who’s affected
Patients using Granix injections for cancer treatment or immune support are likely affected. Those with the specific product lot numbers and expiration dates listed in the recall are at most risk.
How to tell if you have this one
Check for Granix injections with NDC codes 63459-910-11, 63459-910-15, or 63459-910-17. Look for lot numbers 135738, 137149, or 137148 and expiration date 09/30/2025.
- Brand
Teva- Category
Drug
What to do — step by step
Check Product Details
Identify if your Granix injection has the NDC codes and lot numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0218-2025 (January 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0218-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.