# FDA recall D-0527-2026

> **ENDO USA, Inc.** · Class II · drug recall initiated 2026-03-13.

## Product

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

## Reason for recall

Presence of particulate matter: identified as Buprenorphine free base

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0527-2026
- **Recalling firm:** ENDO USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-13
- **Report date:** 2026-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2026

## Citation

> MORVS. FDA recall D-0527-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/D-0527-2026. Source: US FDA. Licensed CC0.

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