Baxter Levofloxacin Injection Recall: High Drug Concentration Risk
Baxter Healthcare recalls specific levofloxacin injection products due to high drug concentration risks. This affects certain lots manufactured in 2018-2019. Contact for details.
Lower-risk recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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What happened, in plain English
Baxter Healthcare is recalling specific levofloxacin injection products because they contain higher-than-specified drug concentrations. This could lead to unsafe medication levels if used as intended. Read more at govinfonow.com/recall/39831-baxter-levofloxacin-injection-recall-high-drug-concentration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39831-baxter-levofloxacin-injection-recall-high-drug-concentration-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1034-2018
Cite this page
“Baxter Levofloxacin Injection Recall: High Drug Concentration Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39831-baxter-levofloxacin-injection-recall-high-drug-concentration-risk. Based on FDA recall #D-1034-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1034-2018%22&limit=1).
Why it’s dangerous
The injection solution has higher-than-specified levofloxacin concentrations. This could lead to unsafe medication levels if used as intended, potentially causing adverse effects.
Who’s affected
Patients prescribed this specific levofloxacin injection by healthcare providers. Those using the product without medical supervision are not affected.
How to tell if you have this one
Check the product label for the specific lot numbers: A061178, A061183, A061236 (expiring 09/18), A0A0937 (expiring 08/19), or A0A1044, A0A1048 (expiring 10/19).
- Brand
Baxter Healthcare- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide USA and Puerto Rico- NDC
36000-045-01, 36000-046-24, 36000-047-24, 36000-048-24
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1034-2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.; Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19 | 191,256 bags |
| D-1035-2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.; Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19 | 106,320 bags |
| D-1036-2018 | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.; Lot #: A060940, A060948, A060951, A060956, A060958, A060963, Exp 07/18; A061105, A061110, A061113, A061115, A061119, Exp 08/18; A061243, Exp 09/18; A0A0813, Exp 07/19; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp 08/19; A0A0971, A0A0976, Exp 09/19; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp 10/19. | 711,216 bags |
What to do — step by step
Check Product Label
Look for lot numbers A061178, A061183, A061236 (expiring 09/18), A0A0937 (expiring 08/19), or A0A1044, A0A1048 (expiring 10/19).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-1034-2018 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1034-2018 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.