Levofloxacin recalls

The FDA has published 11 recalls involving Levofloxacin since 2016. The latest was reported on 7 Jun 2023. Most were for potency & assay. Baxter Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls11since 2016

Last 12 months0reported

Class I00% of total

Ongoing2latest 7 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 55%Class III 5 45%

Why levofloxacin is recalled

Companies

Baxter Healthcare436%
Akorn218%
Claris Lifesciences19%
Cardinal Health19%
Mckesson Medical-Surgical Inc. Corporate Office19%
Macleods Pharma Usa19%
Amerisource Health Services19%

By year

2023327%
202219%
202119%
2018436%
201719%
201619%

Ongoing levofloxacin recalls

2 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Levofloxacin Oral Solution, 25 mg/mL recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion recalled	Akorn	Potency & Assay	Nationwide

All levofloxacin recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Levofloxacin Oral Solution, 25 mg/mL recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma Usa	Packaging Defects	Nationwide
15 Jun 2022Drug	CLASS II	Levofloxacin Tablets, 500 mg unit dose recalledLevofloxacin	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Levofloxacin Injection in 5% Dextrose 500 mg in 5% Dextrose recalledLevofloxacin	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
3 Oct 2018Drug	CLASS III	Levofloxacin Injection in 5% Dextrose, 5 mg/mL recalledLevofloxacin	Baxter Healthcare	Potency & Assay	Nationwide
15 Aug 2018Drug	CLASS III	Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL) recalledLevofloxacin	Baxter Healthcare	Potency & Assay	Nationwide
15 Aug 2018Drug	CLASS III	Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL) recalledLevofloxacin	Baxter Healthcare	Potency & Assay	Nationwide
15 Aug 2018Drug	CLASS III	Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL) recalledLevofloxacin	Baxter Healthcare	Potency & Assay	Nationwide
5 Apr 2017Drug	CLASS II	Levofloxacin Injection in 5% Dextrose, 750 mg in 5% Dextrose recalledLevofloxacin	Claris Lifesciences	Sterility	Nationwide

Should you stop taking Levofloxacin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.