This is part of a larger recall. The most authoritative record is FDA-Drug / D-0082-2027.

FDA-Drug2026-10-26Class IPROCESSING DEFECT

Par Argatroban Injection recalled for particulate matter contamination

METALOTHERPLASTICNationwide distributionDrugs

What this means

Par Pharmaceutical's Argatroban Injection vials have been found to contain small particles of cellulose, polystyrene, polyethylene terephthalate, stainless steel, or stopper material in the solution. This affects specific lot numbers distributed nationwide. The contamination was identified during quality testing.

Check if you have Argatroban Injection lot #84193 (expires 10/2026) or lot #92880 (expires 08/2027).
Do not use affected vials.
Contact your pharmacy or hospital supplier immediately to report and return contaminated vials.
Consult your doctor or healthcare provider about alternative anticoagulation therapy if doses were scheduled.

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The agency's original wording

Hazard

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

Intended for

Adults

Illnesses reported

None reported

Sold states

Nationwide within the United States

Affected count

1944 vials

Manufactured in

870 Parkdale Rd, Rochester, Michigan, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2027

More Paragon 28 recalls

FDA-Drug2026-10-21
Par Health Dexmedetomidine HCl injection recalled for particulate matter contamination
FDA-Drug2026-10-07
Buprenorphine Hydrochloride injection recalled for crystallization

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