Quick answers
- What is Bupivacaine hydrochloride used for?
- The FDA-approved label (Sensorcaine Mpf, Fresenius Kabi USA, LLC, October 15, 2024) says: “Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS ). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bupivacaine hydrochloride have a boxed warning?
- Yes. The FDA label for Sensorcaine Mpf has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bupivacaine hydrochloride?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 29, 2026). Ask your pharmacist about alternatives.
- Has Bupivacaine hydrochloride been recalled?
- FDA enforcement reports list 19 recalls of products of this medicine; the newest started April 2, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bupivacaine hydrochloride?
- 24 companies list prescription products of Bupivacaine hydrochloride in the FDA NDC Directory, including Hospira, Inc., Fresenius Kabi USA, LLC and Eugia US LLC.
What Bupivacaine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS ). …
— FDA label: Sensorcaine Mpf, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
The FDA has 48 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
37 of 48 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Perineural · Epidural · Intracaudal · Infiltration · Retrobulbar · Subarachnoid |
| Prescription products | 104 in the FDA NDC Directory |
| Brand names | Sensorcaine Mpf, Marcaine, Sensorcaine, Marcaine Spinal, Bupivacine HCL, Bupivacaine Spinal |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bupivacaine hydrochloride 2.5 mg/mL injection, solution | Generic | $0.0479 per mL |
| bupivacaine hydrochloride 5 mg/mL injection, solution | Generic | $0.0860 per mL |
NADAC list of November 4, 2026; these prices took effect between April 22, 2026 and May 20, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hospira, Inc.14 products
- Fresenius Kabi USA, LLC11 products
- Eugia US LLC8 products
- Xellia Pharmaceuticals USA LLC8 products
- Henry Schein, Inc.8 products
- Onesource Specialty Pharma Limited8 products
- Hikma Pharmaceuticals USA Inc.8 products
- HF Acquisition Co LLC, DBA HealthFirst7 products
- NorthStar RxLLC6 products
- Anthea Pharma Private Limited5 products
- Asclemed USA, Inc.4 products
- Medical Purchasing Solutions, LLC3 products
- Sportpharm LLC3 products
- Camber Pharmaceuticals, Inc.3 products
- Fosun Pharma USA Inc.2 products
- NorthStar Rx LLC2 products
- Meitheal Pharmaceuticals Inc.2 products
- ProPharma Distribution2 products
- Somerset Therapeutics, LLC2 products
- A-S Medication Solutions1 product
- B. Braun Medical Inc.1 product
- Huons Co., Ltd.1 product
- Cardinal Health 107, LLC1 product
- Brookfield Pharmaceuticals, LLC.1 product
FDA approval history
- 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 | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016964 MARCAINE HYDROCHLORIDE, MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | Hospira | October 3, 1972 | 52, latest August 21, 2020 2020: Labeling · 2018: Labeling · 2014: Manufacturing (CMC) |
| NDA018304 SENSORCAINE | Fresenius Kabi USA | December 30, 1981 | 26, latest July 19, 2022 2022: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
| NDA018692 MARCAINE | Hospira | May 4, 1984 | 10, latest September 28, 2022 2022: Labeling · 2018: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (21)
- ANDA070552Fresenius Kabi USA · May 21, 1986
- ANDA070553Fresenius Kabi USA · May 21, 1986
- ANDA070554Fresenius Kabi USA · May 21, 1986
- ANDA070583Hospira · February 17, 1987
- ANDA070584Hospira · February 17, 1987
- ANDA070590Hospira · February 17, 1987
- ANDA070585Hospira · March 3, 1987
- ANDA070597Hospira · March 3, 1987
- ANDA071810Hospira · December 11, 1987
- ANDA091487Onesource Specialty · October 18, 2011
- ANDA091503Onesource Specialty · October 18, 2011
- ANDA203895Eugia Pharma · November 5, 2013
- ANDA207183Eugia Pharma · May 13, 2016
- ANDA209087B Braun Medical · April 2, 2019
- ANDA212822Huons · December 30, 2019
- ANDA204842Hikma Pharms · February 11, 2021
- ANDA205141Hikma Pharms · February 11, 2021
- ANDA216039Meitheal · June 23, 2023
- ANDA217792Somerset · November 20, 2023
- ANDA217821Aspiro · March 27, 2024
- ANDA220493Anthea Pharma · April 22, 2026
Shortage status
Current shortage · updated October 29, 2026 · first posted February 20, 2018
| Product | Bupivacaine Hydrochloride with Epinephrine, Injection, 25 mg/10 mL (2.5 mg/mL) (NDC 0409-9042-01) |
|---|---|
| Availability | Unavailable |
| Reason given | Other |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 2, 2026 · Class II · Ongoing · D-0530-2026
Lack of Assurance of Sterility
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL — Huons Co., Ltd.
-
November 22, 2022 · Class II · Terminated · D-0127-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose — Fresenius Kabi USA, LLC
-
November 22, 2022 · Class II · Terminated · D-0129-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose V — Fresenius Kabi USA, LLC
-
November 22, 2022 · Class II · Terminated · D-0128-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Via — Fresenius Kabi USA, LLC
-
April 13, 2022 · Class II · Terminated · D-0998-2022
cGMP deviations: Temperature abuse
Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1095-2022
cGMP deviations: Temperature abuse
Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01 — Mckesson Medical-Surgical Inc. Corporate Office
-
May 3, 2021 · Class I · Terminated · D-0626-2021
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake For — PFIZER, INC
-
December 10, 2020 · Class II · Terminated · D-0172-2021
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fr — Fresenius Kabi USA, LLC
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November 11, 2019 · Class II · Terminated · D-0573-2020
Presence of Foreign Substance: Foreign material found inside the vial.
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ — AuroMedics Pharma LLC
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March 28, 2019 · Class I · Terminated · D-1248-2019
Presence of Particulate Matter: One vial was found to contain a hair.
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05 — Aurobindo Pharma USA Inc.
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August 4, 2016 · Class I · Ongoing · D-0218-2017
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 — Hospira Inc., A Pfizer Company
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April 25, 2016 · Class II · Terminated · D-1037-2016
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37 — Fresenius Kabi USA, LLC
-
April 23, 2015 · Class I · Terminated · D-1216-2015
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02. — Hospira Inc.
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September 4, 2014 · Class II · Terminated · D-1588-2014
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-116 — Hospira Inc.
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February 10, 2014 · Class II · Terminated · D-1147-2014
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02 — Hospira Inc.
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October 11, 2013 · Class II · Terminated · D-395-2014
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01. — Hospira Inc.
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September 5, 2013 · Class II · Terminated · D-66295-001
Lack of Assurance of Sterility; potential for vial breakage
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045 — Hospira Inc.
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July 12, 2013 · Class I · Terminated · D-381-2014
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02 — Hospira Inc.
-
July 12, 2013 · Class I · Terminated · D-380-2014
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02 — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1012377, 1012384, 1012391, 1012396, 1012404, 1012413, 1012417, 1012421, 1012455, 1012457 … (+10) |
|---|---|
| SPL set ID of the quoted label | eb6d8fee-def4-4c96-9972-695e8cea8ea8 |
| FDA labels (SPL) | 48 |
| FDA applications | NDA016964, NDA018304, NDA018692, 21 ANDA |
| Active ingredients (FDA) | BUPIVACAINE HYDROCHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sensorcaine Mpf, Fresenius Kabi USA, LLC, effective October 15, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →