Buprenorphine

What Buprenorphine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. …

— FDA label: Butrans, Knoa Pharma LLC, effective May 1, 2026. Read the full label on DailyMed →

The FDA has 50 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. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS. Read it on the full label →

14 of 50 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines that contain Buprenorphine

• Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film · 102 products

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.

• BioDelivery Sciences International Inc7 products
• Bryant Ranch Prepack7 products
• Rhodes Pharmaceuticals LLC7 products
• Braeburn Inc.7 products
• Clinical Solutions Wholesale, LLC6 products
• Remedyrepack Inc.5 products
• Ingenus Pharmaceuticals, LLC5 products
• Amneal Pharmaceuticals NY LLC5 products
• Teva Pharmaceuticals USA, Inc.5 products
• Knoa Pharma LLC5 products
• Aveva Drug Delivery Systems Inc.5 products
• Advagen Pharma Ltd4 products
• Alvogen Inc.4 products
• Direct_Rx3 products
• Hikma Pharmaceuticals USA Inc.3 products
• Actavis Pharma, Inc.2 products
• Sun Pharmaceutical Industries, Inc.2 products
• Camber Pharmaceuticals, Inc.2 products
• PAI Holdings, LLC dba PAI Pharma2 products
• SpecGx LLC2 products
• American Health Packaging2 products
• Major Pharmaceuticals2 products
• A-S Medication Solutions2 products
• AvPAK2 products
• Unit Dose Solutions, Inc.2 products
• Redpharm Drug2 products
• Indivior Inc.2 products
• Gland Pharma Limited1 product
• Hospira, Inc.1 product
• Par Health USA, LLC1 product
• Somerset Therapeutics, LLC1 product
• LTS Therapy Systems, LLC1 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.

Generic approvals (17)

• ANDA074137Hospira · June 3, 1996
• ANDA076931Hikma · March 2, 2005
• ANDA078633Hikma · October 8, 2009
• ANDA090622Ethypharm · September 24, 2010
• ANDA090819Actavis Elizabeth · February 19, 2015
• ANDA090279Rubicon Research · June 10, 2015
• ANDA206586Ph Health · July 28, 2015
• ANDA201760Sun Pharm · January 29, 2016
• ANDA207276Rhodes Pharms · March 27, 2017
• ANDA204937Watson Labs Teva · November 20, 2018
• ANDA211586Amneal · April 14, 2020
• ANDA210272Difgen Pharms · September 23, 2021
• ANDA207490Strides Pharma Intl · May 17, 2022
• ANDA219302Somerset Theraps LLC · January 30, 2025
• ANDA218473Specgx LLC · December 10, 2025
• ANDA219401Ascent Pharms Inc · December 18, 2025
• ANDA221145Gland · October 15, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

1. September 8, 2026 · Class II · Ongoing · D-0876-2026

   Crystallization

   Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05 — Par Health USA, LLC

2. August 19, 2026 · Class III · Ongoing · D-0840-2026

   Labeling: Label Mix-up

   Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11). — American Health Packaging

3. June 12, 2026 · Class II · Ongoing · D-0596-2026

   Crystallization; identified as Buprenorphine free base

   Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 — Par Health USA, LLC

4. March 13, 2026 · Class II · Ongoing · D-0527-2026

   Crystallization; identified as Buprenorphine free base

   Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. — ENDO USA, Inc.

5. May 20, 2024 · Class II · Ongoing · D-0564-2024

   Lack of Assurance of Sterility-The potential for incomplete crimp seals.

   Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 — Pfizer Inc.

6. May 3, 2023 · Class II · Terminated · D-0869-2023

   CGMP Deviations

   Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83. — SUN PHARMACEUTICAL INDUSTRIES INC

7. November 9, 2021 · Class II · Terminated · D-0087-2024

   Crystallization; identified as Buprenorphine free base

   Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-0 — PAR Sterile Products LLC

8. March 15, 2021 · Class II · Terminated · D-0448-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612. — Cardinal Health Inc.

9. March 15, 2021 · Class II · Terminated · D-0449-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA — Cardinal Health Inc.

10. September 4, 2020 · Class II · Terminated · D-0003-2021

    Failed Stability Specifications: Below specification result for buprenorphine release rate.

    Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva — Teva Pharmaceuticals USA

11. August 14, 2020 · Class II · Terminated · D-1533-2020

    Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

    Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA I — Hikma Pharmaceuticals USA Inc.

12. April 28, 2017 · Class II · Terminated · D-0698-2017

    Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.

    Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring — PAR Sterile Products LLC

13. September 9, 2014 · Class II · Terminated · D-1604-2014

    Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.

    Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 04 — Hospira Inc.

Official identifiers

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Butrans, Knoa Pharma LLC, effective May 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. 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 →

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