Xylocaine recalls
Xylocaine products have been recalled 6 times, most recently on 29 Jul 2026. The recalling company is usually Fresenius Kabi USA. The most common reason is manufacturing (cgmp) deviations.
Total recalls6since 2021
Last 12 months3reported
Class I00% of total
Ongoing3latest 29 Jul 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 6 100%Class III 0 0%
Why xylocaine is recalled
Companies
Product types
By year
Ongoing xylocaine recalls
3 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | 2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
All xylocaine recalls, newest first
6 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | 2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Xylocaine + Epinephrine, multi dose vial recalledXylocaine | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xylocaine + Epinephrine, multi dose vial recalledXylocaine | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl recalledXylocaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.