Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24),
Baxter Healthcare recalls specific levofloxacin injection products due to high drug concentration levels in solution. These products were manufactured with out-of-specification results for levofloxacin, potentially causing adverse effects. Affected patients should contact the manufacturer for guidance.
Lower-risk recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Contact the company & request your remedy
What happened, in plain English
Baxter Healthcare is recalling certain levofloxacin injection products because they contain higher-than-specified drug concentrations. This could lead to unintended medical effects if used as intended. Patients with these products should stop using them and contact Baxter for instructions. Read more at govinfonow.com/recall/39554-baxter-levofloxacin-injection-recall-high-drug-concentration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39554-baxter-levofloxacin-injection-recall-high-drug-concentration-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1215-2018
Cite this page
“Baxter Levofloxacin Injection Recall: High Drug Concentration Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39554-baxter-levofloxacin-injection-recall-high-drug-concentration-risk. Based on FDA recall #D-1215-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1215-2018%22&limit=1).
Why it’s dangerous
The recalled injections have higher-than-expected levels of levofloxacin in the solution. This can cause the drug to be more concentrated than intended, potentially leading to adverse reactions when administered.
Who’s affected
Patients who have received the recalled levofloxacin injections in 50mL or 100mL or 150mL sizes with specific lot numbers and expiration dates. Those most at risk are individuals using these medications for medical treatment.
How to tell if you have this one
Check for the product name 'Levofloxacin Injection in 5% Dextrose, 5 mg/mL' with specific packaging sizes (50mL, 100mL, or 150mL). Look for the National Drug Code (NDC) numbers 36000-046-24, 36000-047-24, or 36000-048-24. Also check the lot numbers and expiration dates listed in the recall notice.
- Brand
Baxter Healthcare- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled levofloxacin injections if you have them. Contact Baxter Healthcare for further instructions.
Questions people ask
What is the specific product being recalled?
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in 50mL, 100mL, or 150mL sizes with specific NDC numbers and lot numbers.
How can I check if my product is affected?
Check the product label for the NDC numbers 36000-046-24, 36000-047-24, or 36000-048-24 and the specific lot numbers and expiration dates listed in the recall notice.
What should I do if I have the recalled product?
Immediately stop using the product and contact Baxter Healthcare for instructions on what to do next.
Contact Baxter Healthcare
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-1215-2018 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall D-1215-2018 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1215-2018 (September 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1215-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.