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

> Presence of particulate matter: identified as Buprenorphine free base

**Manufacturer:** ENDO USA, Inc.
**Date of action:** 20260520
**Canonical URL:** https://drugsmonitor.com/recall/76f35c0e-6d98-4a23-80c0-be68d8964e0a
**Last updated:** 2026-06-11

## Summary

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.) — Safety Label Change on 20260520.

Presence of particulate matter: identified as Buprenorphine free base

---

*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*