Buprenorphine Hydrochloride Injection
FDA Recall NDC 42023-179
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Buprenorphine Hydrochloride (NDC 42023-179). A significant event, classified as Class II, was initiated on Mar 13, 2026 by Par Health Usa, Llc. The reported reason for this action was: "Presence of particulate matter: identified as Buprenorphine free base"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of particulate matter: identified as Buprenorphine free base
Mar 13, 2026
May 20, 2026
34,293 vials
Recall Profile & Regulatory Data
Event ID
98610
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ENDO USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Batch or Lot Expiration Information
Lot# : 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Affected Packages Involved in this Recall
42023-179-05Product
Class II Terminated
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Nov 09, 2021
Nov 15, 2023
N/A
Recall Profile & Regulatory Data
Event ID
89016
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PAR Sterile Products LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
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: 42023-179-05
Batch or Lot Expiration Information
Lot# Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
Affected Packages Involved in this Recall
42023-179-05Product
Class II Terminated
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.
Apr 28, 2017
May 17, 2017
122,469 cartons
Recall Profile & Regulatory Data
Event ID
77169
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PAR Sterile Products LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 29, 2018
Product Description
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 Valley, NY 10977.
Batch or Lot Expiration Information
Lot# : 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18.
Affected Packages Involved in this Recall
42023-179-05Product
42023-179-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
