Amide Local Anesthetic, Antiarrhythmic
Where is Epinephrine and Lidocaine made?
14 companies sell it under their own name and 9 repackagers rebottle it. Their labels name 5 factories in the United States and Canada.
United States 4Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC Xylocaine MPF, Xylocaine5 mg per 1 mL / 0.005 mg per 1 mL, 10 mg per 1 mL / 0.005 mg per 1 mL, 10 mg per 1 mL / 0.01 mg per 1 mL, 15 mg per 1 mL / 0.005 mg per 1 mL, 20 mg per 1 mL / 0.005 mg per 1 mL, 20 mg per 1 mL / 0.01 mg per 1 mL · NDC 63323-487, 63323-482, 63323-488 +3 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Hospira, Inc.5 mg per 1 mL / 5 ug per 1 mL, 5 ug per 1 mL / 15 mg per 1 mL, 5 ug per 1 mL / 20 mg per 1 mL, 10 mg per 1 mL / 10 ug per 1 mL, 10 ug per 1 mL / 20 mg per 1 mL · NDC 0409-3178, 0409-0007, 0409-3182 +5 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Benco Dental20 mg per 1 mL / 0.01 mg per 1 mL, 20 mg per 1 mL / 0.02 mg per 1 mL · NDC 66975-425, 66975-415 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Darby Dental Supply, LLC20 mg per 1 mL / 0.01 mg per 1 mL, 20 mg per 1 mL / 0.02 mg per 1 mL · NDC 66467-9730, 66467-9710 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Dentsply Pharmaceutical Inc.10 ug per 1 mL / 20 mg per 1 mL, 20 mg per 1 mL / 20 ug per 1 mL · NDC 66312-176, 66312-181 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Henry Schein, Inc.20 mg per 1 mL / 0.01 mg per 1 mL, 20 mg per 1 mL / 0.02 mg per 1 mL · NDC 0404-6512, 0404-6500 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| NDC, Inc.20 mg per 1 mL / 0.01 mg per 1 mL · NDC 43128-105 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Novocol Pharmaceutical of Canada, Inc.20 mg per 1 mL / 0.01 mg per 1 mL · NDC 51004-2105 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Patterson Dental Supply, Inc.20 mg per 1 mL / 0.01 mg per 1 mL, 20 mg per 1 mL / 0.02 mg per 1 mL · NDC 50227-1030, 50227-1020 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Safco Dental Supply Co.20 mg per 1 mL / 0.01 mg per 1 mL · NDC 67239-0240 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Septodont, Inc. Flavalta20 mg per 1 mL / 0.01 mg per 1 mL, 20 mg per 1 mL / 0.02 mg per 1 mL · NDC 0362-1095, 0362-1200, 0362-0898 +2 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| The Atlanta Dental Supply Company DBA Advanced Dental Products20 mg per 1 mL / 0.01 mg per 1 mL · NDC 71347-210 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| B. Braun Medical Inc.15 mg per 1 mL / 0.005 mg per 1 mL · NDC 0264-9378 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IT3 Medical LLC10 mg per 1 mL / 10 ug per 1 mL · NDC 70529-100 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Epinephrine and Lidocaine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3321,50090-6851 - Cardinal Health 107, LLC:
55154-0132 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1405,51662-1589,51662-1622,51662-1395+7 - Henry Schein, Inc.:
0404-9977,0404-9891,0404-9788,0404-9896+4 - Physicians Total Care, Inc.:
54868-1796 - ProPharma Distribution:
84549-482,84549-182 - Remedyrepack Inc.:
70518-4152 - Sportpharm LLC:
85766-190,85766-073 - US MedSource, LLC:
61699-3178,61699-3182
Recalls
- Jul 16, 2026 · Class II · Fresenius Kabi USA, LLC · 2 recall notices
Presence of Particulate Matter: Hair was found in products - Oct 31, 2025 · Class II · Novocol Pharmaceutical of Canada, Inc. · 2 recall notices
Defective container: cracked/broken cartridges - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office · 2 recall notices
cGMP deviations: Temperature abuse - Jun 25, 2021 · Class II · Fresenius Kabi USA LLC
Low out of specification results for epinephrine assay. - Aug 14, 2013 · Class II · Novocol Pharmaceutical of Canada
Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.