ARGATROBAN
Recalling Firm / Manufacturer: Par Health USA, LLC
(Rochester, MI, United States)
FDA Recall Number: D-0083-2027
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ARGATROBAN
Generic Name
ARGATROBAN
Active Substance(s)
Argatroban
Administration Route
Intravenous
National Drug Code (NDC)
42023-182
Total Quantity Recalled
1944 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
October 28, 2026
Firm Initiation Date
October 13, 2026
FDA Classification Date
Oct 26, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
Distribution Information
Geographic scope of affected shipments
Nationwide within the United States
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0083-2027
Questo Retrieval Date: November 03, 2026 00:00 1793664008UTCC