Baxter Fluconazole Injection Recall: Leaking Bags Risk Infection
Baxter recalls Fluconazole Injection (200 mg/100 mL) due to leaking bags that could cause infection. Affected lots expire Dec 2017. Stop using immediately.
Stop using this now
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Contact the company
What happened, in plain English
Baxter is recalling Fluconazole Injection vials that may leak, risking infection. Patients should stop using these products immediately as they could cause serious health issues. Read more at govinfonow.com/recall/42139-baxter-fluconazole-injection-recall-leaking-bags-risk-infection.
Source Summary by GovInfoNow · govinfonow.com/recall/42139-baxter-fluconazole-injection-recall-leaking-bags-risk-infection · Updated October 8, 2026 · FDA enforcement record: FDA #D-0206-2017
Cite this page
“Baxter Fluconazole Injection Recall: Leaking Bags Risk Infection.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42139-baxter-fluconazole-injection-recall-leaking-bags-risk-infection. Based on FDA recall #D-0206-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0206-2017%22&limit=1).
Why it’s dangerous
Leaking bags can contaminate the medication with bacteria, leading to infections. This is confirmed by customer complaints about leaks in the product.
Who’s affected
Patients prescribed Fluconazole Injection by a doctor. Those using the recalled vials are at highest risk of infection.
How to tell if you have this one
Check for product code 2J1446, NDC 0338-6046-48, or lot number P344028 on the vial and P344028A on the shipping container. The vials expire December 31, 2017.
- Brand
Baxter- Category
Drug
What to do — step by step
Stop Using Immediately
Discard the recalled Fluconazole Injection vials as they may leak and cause infection.
How this recall unfolded
Recall timeline
FDA terminated this recall 14 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-0206-2017 (December 6, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0206-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.