Quick answers
- What is Bupivacaine used for?
- The FDA-approved label (Exparel, Pacira Pharmaceuticals, Inc., December 12, 2025) says: “EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal fossa in adults Regional analgesia via an adductor canal block in adults EXPAREL contains bupivacaine, an amide local anesthetic, and is indicated to produce …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bupivacaine have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bupivacaine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bupivacaine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 21, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bupivacaine?
- 2 companies list prescription products of Bupivacaine in the FDA NDC Directory, including Jiangsu Hengrui Pharmaceuticals Co., Ltd. and Pacira Pharmaceuticals, Inc..
What Bupivacaine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal fossa in adults Regional analgesia via an adductor canal block in adults EXPAREL contains bupivacaine, an amide local anesthetic, and is indicated to produce …
— FDA label: Exparel, Pacira Pharmaceuticals, Inc., effective December 12, 2025. Read the full label on DailyMed →
The FDA has 2 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.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, suspension, liposomal |
|---|---|
| Route | Infiltration |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Exparel |
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.
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.2 products
- Pacira Pharmaceuticals, Inc.2 products
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 |
|---|---|---|---|
| NDA022496 EXPAREL | Pacira Pharms Inc | October 28, 2011 | 22, latest November 28, 2023 2023: Labeling · 2023: Efficacy · 2021: Manufacturing (CMC) |
Generic approvals (1)
- ANDA214348Hengrui Pharma · July 1, 2024
Shortage status
The FDA drug shortage list does not show these products.
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.
-
November 21, 2019 · Class II · Terminated · D-0621-2020
Sub Potent Drug: Out of Specification (OOS)
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20, — Pacira Pharmaceuticals, 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) | 1191508, 1191513, 1745061, 1745062 |
|---|---|
| SPL set ID of the quoted label | bb5a9e59-0f51-11df-8a39-0800200c9a66 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA022496, 1 ANDA |
| Active ingredients (FDA) | BUPIVACAINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Exparel, Pacira Pharmaceuticals, Inc., effective December 12, 2025; 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 →