FDA Drug · D-0083-2027

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.

Class I · Ongoing

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

Affected lots / codes — check yours against thisLot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.

Recalling firm: Par Health USA, LLC, Rochester, MI
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: 1944 vials
Distribution: Nationwide within the United States
Recall initiated: October 13, 2026
Classified: October 26, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0083-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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