---
title: Par Health USA, LLC Issues Class I Drug Recall for Argatroban Injection
canonical: https://federalfeed.com/par-health-usa-llc-issues-class-i-drug-recall-for-argatroban-injection/
published: '2026-11-02T17:32:03-05:00'
updated: '2026-11-02T17:32:03-05:00'
author: FederalFeed Staff
section: Medicine & Device Recalls
tags:
- FDA
source: Food and Drug Administration
source_url: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072
publisher: FederalFeed
attribution: Copyright FederalFeed. Quote with credit to FederalFeed and a link to the canonical URL above.
---

# Par Health USA, LLC Issues Class I Drug Recall for Argatroban Injection

Par Health USA, LLC announced a Class I recall of Argatroban Injection, USP, 250 mg/2.5mL, on October 13, 2026. The recall affects products distributed nationwide and is ongoing due to the presence of particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution. Details of the recall can be found in the FDA's weekly enforcement report [here](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072).

---

### Press Release: Food and Drug Administration

*Published October 28, 2026. Reproduced in full from the [Food and Drug Administration](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072).*

#### Par Health USA, LLC drug recall

- Recalling company: Par Health USA, LLC
- Classification: Class I (the most serious type)
- Recall numbers: D-0082-2027, D-0083-2027
- Status: Ongoing
- Distribution: Nationwide within the United States
- Recall started: October 13, 2026

#### What was recalled

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.

#### Why

Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

This drug recall appears in the FDA's weekly enforcement report. Details: [FDA recall event 100072](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072).

Source: [Food and Drug Administration](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100072)