Lidocaine recalls

The FDA has published 120 recalls involving Lidocaine since 2012. The latest was reported on 23 Sep 2026. Most were for sterility. Pharmedium Services 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 recalls120since 2012
Last 12 months13reported
Class I1412% of total
Ongoing28latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 14 12%Class II 98 82%Class III 8 7%

By year

Ongoing lidocaine recalls

28 active

All lidocaine recalls, newest first

120 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaineSUN Pharma /TaroPotency & AssayNationwide
DrugCLASS IIXylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaineFresenius Kabi USAParticulate MatterNationwide
DrugCLASS IIILidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog KitAsclemed USAOtherTN
DrugCLASS IILidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaineFresenius Kabi USAParticulate MatterNationwide
DrugCLASS IIXylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaineFresenius Kabi USAParticulate MatterNationwide
DrugCLASS IILidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine HydrochlorideAsclemed USASterilityNationwide
DrugCLASS IIAccucaine, Kit contains: Lidocaine HCl Injection recalledAccucaineAsclemed USASterilityNationwide
DrugCLASS IIILidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog KitEugia USOtherNationwide
DrugCLASS IILidocaine HCl Injection USP, mL, Single-Dose Ampules recalledLidocaine HydrochlorideSpectra Medical DevicesSterilityNationwide
DrugCLASS IILidocaine HCl Injection, USP, 2%, 100 mg recalled by Huons CoLidocaine HydrochlorideHuonsSterilityNationwide
DrugCLASS IILidocaine HCl injection, USP, 1% 50mg/ (10 mg/mL) Single Dose Vials recalledLidocaine HydrochlorideHuonsSterilityNationwide
DrugCLASS IILidocaine HCI 2% and Epinephrine 1:100 recalledLidocaineNovocol Pharmaceutical of CanadaPackaging DefectsNationwide
DrugCLASS II2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaineNovocol Pharmaceutical of CanadaPackaging DefectsNationwide
DrugCLASS IILIDOcaine HCL Sterile Injection, USP, 20 mg/mL recalledTailstorm HealthSterilityNationwide
DrugCLASS IILIDOcaine HCl Injection, USP, 10mg/mL recalled by Tailstorm HealthTailstorm HealthSterilityNationwide
DrugCLASS IILIDOcaine HCL Sterile Injection, USP, 100mg/, 1%, (10mg/mL) recalledTailstorm HealthSterilityNationwide
DrugCLASS IIEquate Maximum Strength Lidocaine Pain Relieving Patch recalledEquate Pain Relieving PatchesUnexo Life Sciences PrivateManufacturing (CGMP) DeviationsNationwide
DrugCLASS IITheracare Maximum Strength Pain Relief 4% Lidocaine Patch recalledTheracare Maximum Strength Pain Relief PatchUnexo Life Sciences PrivateManufacturing (CGMP) DeviationsNationwide
DrugCLASS IILidocaine HCl Injection, 2% (20mg per mL) (100 mg per syringe recalledFagron Compounding ServicesSterilityNationwide
DrugCLASS IILidocaine HCL Injection, USP 2% 200mg/ (20mg/mL) recalledTailstorm HealthPotency & AssayNationwide
DrugCLASS IILidocaine HCL 1% (10mg/mL), PHENYLephrine HCL recalledDenver SolutionsParticulate MatterNationwide
DrugCLASS I1% Lidocaine HCl Injection, USP, 50mg/(10mg/mL) recalled by PfizerPfizerParticulate MatterNationwide
DrugCLASS I2% Lidocaine HCl Injection, USP, 100mg/(20mg/mL) recalled by PfizerPfizerParticulate MatterNationwide
DrugCLASS IILidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution recalledPine PharmaceuticalsSterilityNationwide
DrugCLASS IIlidocaine 2%, 100 mg/, (20 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
DrugCLASS IIlidocaine 2%, 100 mg /, (20 mg/mL) Syringe recalledCentral Admixture Pharmacy ServicesSterilityNationwide
DrugCLASS IILidocaine Ointment USP, 5%, 1 tubes recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IILidocaine Hydrochloride Oral Topical Solution recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IIILidocaine Patch 5%, 1 patch (63629-8755-20) recalledLidocaineBryant Ranch PrepackPackaging DefectsNationwide
DrugCLASS IILidocaine/Phenylephrine PF Syr 1%/1.5% Solution syringes recalledPharmacy PlusSterility4 states

Should you stop taking Lidocaine?

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.