Quick answers
- What is Xylocaine?
- Xylocaine is a brand name of Lidocaine hydrochloride,epinephrine bitartrate, Lidocaine and Lidocaine hydrochloride and epinephrine, a prescription medicine. The FDA NDC Directory lists 24 Xylocaine products in 9 strengths and forms.
- Who makes Xylocaine?
- Fresenius Kabi USA holds the FDA application for Xylocaine (NDA006488, approved November 19, 1948). 8 other companies (repackagers or distributors) also list Xylocaine products.
- Is there a generic or store brand of Xylocaine?
- Yes. The FDA NDC Directory lists 32 other products with the same active ingredients, strength and form as a Xylocaine product, 14 of them generic. Ask your pharmacist whether one is right for you.
- Has Xylocaine been recalled?
- FDA enforcement reports list 6 recalls of Xylocaine products; the newest started July 16, 2026. A recall usually concerns specific lots, not every product.
What Xylocaine is
Each Xylocaine product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Lidocaine hydrochloride,epinephrine bitartrate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| epinephrine bitartrate 0.005 mg/mL · lidocaine hydrochloride anhydrous 20 mg/mL injection, solution (epidural, infiltration, intracaudal, perineural) | Xylocaine | 3 products, 2 companies | DailyMed |
| epinephrine bitartrate 0.005 mg/mL · lidocaine hydrochloride anhydrous 5 mg/mL injection, solution (infiltration, perineural) | Xylocaine | None listed | DailyMed |
| epinephrine bitartrate 0.01 mg/mL · lidocaine hydrochloride anhydrous 10 mg/mL injection, solution (infiltration, perineural) | Xylocaine | None listed | DailyMed |
| epinephrine bitartrate 0.01 mg/mL · lidocaine hydrochloride anhydrous 20 mg/mL injection, solution (infiltration, perineural) | Xylocaine | 2 products, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lidocaine hydrochloride,epinephrine bitartrate →
Lidocaine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| lidocaine hydrochloride anhydrous 10 mg/mL injection, solution (infiltration, perineural) | Xylocaine | 13 products, 7 companies | DailyMed |
| lidocaine hydrochloride anhydrous 20 mg/mL injection, solution (infiltration, perineural) | Xylocaine | 12 products, 7 companies | DailyMed |
| lidocaine hydrochloride anhydrous 5 mg/mL injection, solution (infiltration, perineural) | Xylocaine | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lidocaine →
Lidocaine hydrochloride and epinephrine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| epinephrine bitartrate 10 ug/mL · lidocaine hydrochloride 20 mg/mL injection, solution (submucosal) | Xylocaine | None listed | DailyMed |
| epinephrine bitartrate 20 ug/mL · lidocaine hydrochloride 20 mg/mL injection, solution (submucosal) | Xylocaine | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lidocaine hydrochloride and epinephrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA006488 | Fresenius Kabi USA | November 19, 1948 | 22 |
| ANDA088390 | Deproco | January 22, 1985 | 1 |
| ANDA088389 | Deproco | September 30, 2009 | 1 |
Companies that list Xylocaine
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Xylocaine products.
- Fresenius Kabi USA, LLC6 products
- Henry Schein, Inc6 products
- HF Acquisition Co LLC, DBA HealthFirst4 products
- Sportpharm LLC2 products
- Dentsply Pharmaceutical2 products
- Remedyrepack Inc.1 product
- Asclemed USA, Inc.1 product
- A-S Medication Solutions1 product
- ProPharma Distribution1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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July 16, 2026 · Class II · Ongoing · D-0728-2026
Presence of Particulate Matter: Hair was found in products
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01 — Fresenius Kabi USA, LLC
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July 16, 2026 · Class II · Ongoing · D-0729-2026
Presence of Particulate Matter: Hair was found in products
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03 — Fresenius Kabi USA, LLC
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October 31, 2025 · Class II · Ongoing · D-0228-2026
Defective container: cracked/broken cartridges
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, Yor — Novocol Pharmaceutical of Canada, Inc.
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April 13, 2022 · Class II · Terminated · D-1052-2022
cGMP deviations: Temperature abuse
Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC — Mckesson Medical-Surgical Inc. Corporate Office
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April 13, 2022 · Class II · Terminated · D-1053-2022
cGMP deviations: Temperature abuse
Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27 — Mckesson Medical-Surgical Inc. Corporate Office
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June 25, 2021 · Class II · Terminated · D-0651-2021
Low out of specification results for epinephrine assay.
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. — Fresenius Kabi USA LLC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.