Teva Recalls Linezolid Injection Due to Sterility Risk
Teva North America recalls specific lots of Linezolid Injection bags due to potential leaking and lack of sterility assurance. Nationwide distribution.
Use caution until it’s fixed
Lack of Assurance of Sterility: Due to potential for leaking bags.
Contact the company
What happened, in plain English
Teva North America is recalling a small quantity of Linezolid Injection bags because the packaging may leak, which compromises the assurance of sterility. The affected product was manufactured in Hungary and distributed nationwide. No remedy or return instructions are currently provided in the record. Read more at govinfonow.com/recall/42858-teva-recalls-linezolid-injection-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42858-teva-recalls-linezolid-injection-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0868-2016
Cite this page
“Teva Recalls Linezolid Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42858-teva-recalls-linezolid-injection-due-to-sterility-risk. Based on FDA recall #D-0868-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2016%22&limit=1).
Why it’s dangerous
The primary hazard is a potential leak in the single-use container bags. This leakage creates a risk that the drug may not be sterile, which can lead to serious infections if administered to a patient.
Who’s affected
Patients who received Linezolid Injection from this specific lot for medical treatment. Healthcare providers administering this medication to patients are also affected.
How to tell if you have this one
Check for Linezolid Injection, 600 mg/300 mL Single use container bags with NDC 0703-9060-31. Look for Lot # 2520715 and an expiration date of 7/17. The product was manufactured by Teva Pharmaceutical Works Ltd. in Hungary.
- Brand
Teva North America- Category
Drug
What to do — step by step
Identify the Product
Verify if you have Linezolid Injection bags with NDC 0703-9060-31, Lot # 2520715, expiring 7/17.
Contact Healthcare Provider
Consult your doctor or pharmacist immediately regarding the sterility risk and potential need for replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0868-2016 (April 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0868-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.