HIGH

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

Presence of particulate matter: identified as Buprenorphine free base

Quick Facts at a Glance

Recall Date
March 13, 2026
Hazard Level
HIGH
Brands
BUPRENORPHINE HYDROCHLORIDE, Par Health USA, LLC
Geographic Scope
1 states

Hazard Information

Presence of particulate matter: identified as Buprenorphine free base

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ENDO USA, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: BUPRENORPHINE HYDROCHLORIDE; Brand: BUPRENORPHINE HYDROCHLORIDE. Reason: Presence of particulate matter: identified as Buprenorphine free base. Classification: Class II. Quantity: 34,293 vials. Distribution: USA Nationwide

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot #: 84132
Exp 02/28/2027
87693
Exp 03/31/2027
UPC Codes
42023-179
42023-179-05
Affected States
ALL
Report Date
May 20, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE