CLASS II ONGOING Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report

Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion recalled

Akorn is recalling Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion, distributed nationwide in the US. The recall was initiated on 26 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0818-2023
FDA event ID
91788
Recalling firm
Akorn, Gurnee, IL
Classification
Class II
Status
Ongoing
Recall initiated
26 Apr 2023
FDA classified
1 Jun 2023
Reported
7 Jun 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay
Drug class
Antibiotics

Timeline

26 Apr 2023Recall initiated by company
1 Jun 2023Classified by FDA+36 days
7 Jun 2023Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Where it was distributed

Nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Which lots are affected?

All Lots

Where was it sold?

Nationwide in the USA and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

85 other products · FDA event 91788
ReportedClassRecallCompanyReasonWhere
CLASS IIClobetasol Propionate Cream recalled by AkornAkornPotency & AssayNationwide
CLASS IILevofloxacin Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IITropicamide Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IICalcitriol Injection 1 mcg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IISodium Chloride Ophthalmic Ointment, USP, 5% tubes recalled by AkornAkornPotency & AssayNationwide
CLASS IIAzelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recalledAkornPotency & AssayNationwide
CLASS IILevocarnitine Oral Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IICiclopirox Topical Solution 8% (Nail Lacquer) recalled by AkornAkornPotency & AssayNationwide
CLASS IIArtificial Tears Ointment, Sterile, For Ophthalmic Use Only tubes recalledAkornPotency & AssayNationwide
CLASS IILidocaine 2.5% & Prilocaine 2.5% Cream tubes recalled by AkornAkornPotency & AssayNationwide
CLASS IIMegestrol Acetate Oral Suspension, USP 40 mg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIFerrous Sulfate Iron Supplement Drops recalled by AkornAkornPotency & AssayNationwide
CLASS IIArtificial Tears Solution, Polyvinyl Alcohol recalled by AkornAkornPotency & AssayNationwide
CLASS IIOlopatadine HCl Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIClobetasol Propionate Ointment, USP, 0.05% tubes recalled by AkornAkornPotency & AssayNationwide
CLASS IIRifampin Capsules USP, 300 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIEphedrine Sulfate Injection recalled by AkornAkornPotency & AssayNationwide
CLASS IIRopivacaine Hydrochloride Injection USP, 0.2%, 200mg/ (2 mg/mL) Vial recalledAkornPotency & AssayNationwide
CLASS IIAtropine Sulfate Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIAk-poly-bac (bacitracin Zinc recalled by AkornAkornPotency & AssayNationwide
CLASS IILorazepam Injection, USP 2 mg/mL vial vials recalled by AkornAkornPotency & AssayNationwide
CLASS IINaloxone Injection, USP 0.4 mg/mL, For Intravenous recalled by AkornAkornPotency & AssayNationwide
CLASS IICromolyn Sodium Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIIC-Green (indocyanine green for injection, USP) 25 mg/ Kit recalledAkornPotency & AssayNationwide
CLASS IIAmantadine Hydrochloride Oral Solution USP, 50mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIPilocarpine Hydrochloride Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IILevofloxacin Oral Solution, 25 mg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIDicyclomine Hydrochloride Injection USP, 20 mg/ (10 mg/mL) ampules recalledAkornPotency & AssayNationwide
CLASS IIDiuril (chlorothiazide sodium) Injection, 500mg/vial recalled by AkornAkornPotency & AssayNationwide
CLASS IIFentanyl Citrate Injection, USP 100 mcg/ (50 mcg/mL) recalled by AkornAkornPotency & AssayNationwide
CLASS IIPrednisolone Oral Solution, USP, 15 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIValproic Acid Oral Solution, USP, 250mg recalled by AkornAkornPotency & AssayNationwide
CLASS IITobramycin Inhalation Solution USP, 300 mg/-dose ampules recalledAkornPotency & AssayNationwide
CLASS IITobramycin Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIGuaifenesin Oral Solution, 300 mg/, Sugar Free/Alcohol Free recalledAkornPotency & AssayNationwide
CLASS IIApraclonidine Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIAcetaminophen & Codeine Phosphate Oral Solution 120mg/12mg recalledAkornPotency & AssayNationwide
CLASS IILidocaine Hydrochloride Oral Topical Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IILidocaine HCl Jelly USP, 2% tubes recalled by AkornAkornPotency & AssayNationwide
CLASS IILevetiracetam Oral Solution 100 mg/mL (100 mg/mL) recalled by AkornAkornPotency & AssayNationwide
CLASS IISodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IICetrorelix Acetate for Injection, 0.25 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIHydrALAZINE HCl Injection, USP, 20 mg/mL Single Dose vials recalledAkornPotency & AssayNationwide
CLASS IIGuaiatussin AC Sugar-Free, Each teaspoonful contains recalled by AkornAkornPotency & AssayNationwide
CLASS IIHydrocortisone and Acetic Acid Otic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IISulfamethoxazole & Trimethoprim Oral Suspension recalled by AkornAkornPotency & AssayNationwide
CLASS IILorazepam Oral Concentrate, USP, 2mg per mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIOlopatadine HCl Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IILactulose Solution, USP (For oral or rectal administration) recalledAkornPotency & AssayNationwide
CLASS IICimetidine HCl Oral Solution 300mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIHydromorphone Hydrochloride Injection, USP, 50mg/ (10 mg/mL) recalledAkornPotency & AssayNationwide
CLASS IIXopenex (levalbuterol HCl) Inhalation Solution Concentrate recalledAkornPotency & AssayNationwide
CLASS IIPilocarpine Hydrochloride Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIVitamin D Supplement Drops, 400 IU, Cherry Flavored recalled by AkornAkornPotency & AssayNationwide
CLASS IIRifampin Capsules USP, 150 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IISodium Diuril (chlorothiazide sodium), Single-dose recalled by AkornAkornPotency & AssayNationwide
CLASS IIPromethazine HCl & Codeine Phosphate Oral Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIRopivacaine Hydrochloride Injection USP, 0.5%, 150mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIMoxifloxacin HCl Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIDetomiSed (detomidine hydrochloride) recalled by AkornAkornPotency & AssayNationwide
CLASS IIProparacaine HCl Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIPromethazine HCl Oral Solution, USP, 6.25 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IITrihexyphenidyl Hydrochloride Oral Solution, USP, 2mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalledAkornPotency & AssayNationwide
CLASS IIClobetasol Propionate Shampoo recalled by AkornAkornPotency & AssayNationwide
CLASS IILactulose Solution, USP (Oral) recalled by AkornAkornPotency & AssayNationwide
CLASS IISufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIAcyclovir Oral Suspension, 200mg recalled by AkornAkornPotency & AssayNationwide
CLASS IITropicamide Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IINeomycin & Polymyxin B Sulfates recalled by AkornAkornPotency & AssayNationwide
CLASS IIAcetic Acid Otic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIDocu Liquid (docusate sodium, 50 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IICalcitriol Injection 2 mcg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIAlbuterol Sulfate Syrup, 2mg (base) recalled by AkornAkornPotency & AssayNationwide
CLASS IIPilocarpine Hydrochloride Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
CLASS IIOxcarbazepine Oral Suspension, USP, 300 mg recalled by AkornAkornPotency & AssayNationwide
CLASS IIOlopatadine HCl Nasal Spray, 665 mcg recalled by AkornAkornPotency & AssayNationwide
CLASS IIGonak Hypromellose Ophthalmic Solution 25mg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIFluticasone Propionate Nasal Spray, 50mcg recalled by AkornAkornPotency & AssayNationwide
CLASS IIGranisetron HCl Injection, USP, 1 mg/mL recalled by AkornAkornPotency & AssayNationwide
CLASS IIMidazolam Injection, USP 2mg recalled by AkornAkornPotency & AssayNationwide
CLASS IILidocaine Ointment USP, 5%, 1 tubes recalled by AkornAkornPotency & AssayNationwide
CLASS IIMidazolam Injection, USP, 50 mg/ (5mg/mL) recalled by AkornAkornPotency & AssayNationwide
CLASS IICalcipotriene Topical Solution, 0.005% (Scalp Solution) recalledAkornPotency & AssayNationwide
CLASS IITimolol Maleate Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide

More recalls from Akorn

All 192
ReportedClassRecallCompanyReasonWhere
DrugCLASS IITimolol Maleate Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IICalcipotriene Topical Solution, 0.005% (Scalp Solution) recalledAkornPotency & AssayNationwide
DrugCLASS IIMidazolam Injection, USP, 50 mg/ (5mg/mL) recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IILidocaine Ointment USP, 5%, 1 tubes recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IIMidazolam Injection, USP 2mg recalled by AkornAkornPotency & AssayNationwide

Other Levofloxacin recalls

All 19
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILevofloxacin Oral Solution, 25 mg/mL recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IILevofloxacin Ophthalmic Solution recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IIILevofloxacin Tablets, USP 500 mg recalled by Macleods Pharma UsaMacleods Pharma USAPackaging DefectsNationwide
DrugCLASS IILevofloxacin Tablets, 500 mg unit dose recalledLevofloxacinMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide
DrugCLASS IILevofloxacin Injection in 5% Dextrose 500 mg in 5% Dextrose recalledLevofloxacinCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC