Pain Medication recalls

The FDA has published 1,518 recalls involving pain medication 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 recalls1,518since 2012
Last 12 months47reported
Class I856% of total
Ongoing166latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 85 6%Class II 1,300 86%Class III 133 9%

By year

Ongoing pain medication recalls

166 active

All pain medication recalls, newest first

1,518 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaineSUN Pharma /TaroPotency & AssayNationwide
DrugCLASS IIfentaNYL Citrate, 1,000 mcg recalled by OurPharmaOurPharmaOtherNationwide
DrugCLASS IMorphine Sulfate Injection recalled by Fresenius Kabi USAMorphine SulfateFresenius Kabi USAPackaging DefectsNationwide
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 IIfentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalledIntegraDose Compounding ServicesPotency & AssayNationwide
DrugCLASS IINaproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxenAcella PharmaceuticalsLead & Heavy MetalsNationwide
DrugCLASS IIfentaNYL Citrate Injectable Solution recalled by Wells Pharma of HoustonWells Pharma of HoustonManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIILidocaine Wound Gel (Benzalkonium Chloride recalledWater-Jel TechnologiesOtherNationwide
DrugCLASS IIfentaNYL Citrate Injectable Solution, Narcotic, CII recalledWells Pharma of HoustonManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIfentaNYL Citrate Injectable Solution, Narcotic, Cii recalledWells Pharma of HoustonManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIfentaNYL Citrate injectable Solution recalled by Wells Pharma of HoustonWells Pharma of HoustonManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIfentaNYL Citrate Injectable Solution recalled by Wells Pharma of HoustonWells Pharma of HoustonManufacturing (CGMP) DeviationsNationwide
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 IItraMADol Hydrochloride Tablets, USP, 50 mg recalledAmneal PharmaceuticalsNitrosamine ImpurityNationwide
DrugCLASS IIChildren's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofenStrides PharmaParticulate MatterNationwide
DrugCLASS IIMaximum, Zone 1, 4% Lidocaine Cream recalled by HTO NevadaHTO NevadaPotency & AssayNationwide
DrugCLASS IIMaximum, Zone 2, 4% Lidocaine Cream, (Lidocaine recalled by HTO NevadaHTO NevadaPotency & AssayNationwide
DrugCLASS IIFive-star, Vasocaine Spray, (Lidocaine HCl recalled by HTO NevadaHTO NevadaPotency & AssayNationwide
DrugCLASS IIFor Sensitive Skin, 4% Lidocaine, [ or] recalledPro Numb Sensitive SkinPro Numb Tattoo Numbing SprayManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIOxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone HydrochlorideAmerisource Health ServicesPackaging DefectsNationwide
DrugCLASS II5% Lidocaine, [ or] recalled by Pro Numb Tattoo Numbing SprayPro NumbPro Numb Tattoo Numbing SprayManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDiclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac SodiumSUN Pharmaceutical IndustriesPotency & AssayNationwide

Should you stop taking Pain Medication?

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.