# FDA recall D-0596-2026

> **Par Health USA, LLC** · Class II · drug recall initiated 2026-06-12.

## Product

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

## Reason for recall

Crystallization; identified as Buprenorphine free base

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0596-2026
- **Recalling firm:** Par Health USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-06-12
- **Report date:** 2026-06-24

- **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-0596-2026

## Citation

> MORVS. FDA recall D-0596-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/D-0596-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*