Levofloxacin recalls
The FDA has published 19 recalls involving Levofloxacin since 2012. The latest was reported on 7 Jun 2023. Most were for potency & assay. AuroMedics Pharma 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 recalls 19 since 2012
Last 12 months 0 reported
Class I 1 5% of total
Ongoing 4 latest 7 Jun 2023
Recalls per month, last 24 months click a bar for that month Severity split
1 5%12 63%6 32%
Why levofloxacin is recalled
Ongoing levofloxacin recalls 4 active
All levofloxacin recalls, newest first 19 total Reported Class Recall Company Reason Where 7 Jun 2023 Drug CLASS II Levofloxacin Oral Solution, 25 mg/mL recalled by Akorn Akorn Potency & Assay Nationwide 7 Jun 2023 Drug CLASS II Levofloxacin Ophthalmic Solution recalled by Akorn Akorn Potency & Assay Nationwide 7 Jun 2023 Drug CLASS II Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion recalled Akorn Potency & Assay Nationwide 25 Jan 2023 Drug CLASS III Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa Macleods Pharma USA Packaging Defects Nationwide 15 Jun 2022 Drug CLASS II Levofloxacin Tablets, 500 mg unit dose recalled Levofloxacin Mckesson Medical-Surgical Inc. Corporate Office Manufacturing (CGMP) Deviations Nationwide 2 Jun 2021 Drug CLASS II Levofloxacin Injection in 5% Dextrose 500 mg in 5% Dextrose recalled Levofloxacin Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 3 Oct 2018 Drug CLASS III Levofloxacin Injection in 5% Dextrose, 5 mg/mL recalled Levofloxacin Baxter Healthcare Potency & Assay Nationwide 15 Aug 2018 Drug CLASS III Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL) recalled Levofloxacin Baxter Healthcare Potency & Assay Nationwide 15 Aug 2018 Drug CLASS III Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL) recalled Levofloxacin Baxter Healthcare Potency & Assay Nationwide 15 Aug 2018 Drug CLASS III Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL) recalled Levofloxacin Baxter Healthcare Potency & Assay Nationwide 9 May 2018 Drug CLASS II Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin recalled Levofloxacin AuroMedics Pharma Mold Nationwide 9 May 2018 Drug CLASS II Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin recalled Levofloxacin AuroMedics Pharma Mold Nationwide 9 May 2018 Drug CLASS II Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin recalled Levofloxacin AuroMedics Pharma Mold Nationwide 7 Mar 2018 Drug CLASS I Levofloxacin in 5% Dextrose Injection, 250 mg recalled Levofloxacin AuroMedics Pharma Mold Nationwide 5 Apr 2017 Drug CLASS II Levofloxacin Injection in 5% Dextrose, 750 mg in 5% Dextrose recalled Levofloxacin Claris Lifesciences Sterility Nationwide 15 Mar 2017 Drug CLASS III Levofloxacin Ophthalmic Solution, 0.5%, Sterile recalled by Actavis Actavis Potency & Assay Nationwide 3 Feb 2016 Drug CLASS II Levofloxacin Tablets USP, 500 mg recalled by Amerisource Health Services Amerisource Health Services Potency & Assay Nationwide 30 Jul 2014 Drug CLASS II Levofloxacin 750 mg/ D5W, Trinity Care Solutions recalled Franck's Lab Sterility FL 22 Aug 2012 Drug CLASS II Levofloxacin, P.f. (premixed Solution) 5mg/ML Injectable recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab 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.