Par Health USA announced a nationwide recall of 22 batches of Argatroban Injection, a hospital-administered anticoagulant, after foreign particles were found in certain vials. The recall, effective October 13, 2026, covers lots distributed between December 30, 2024, and May 5, 2026. The identified contaminants include cellulose, polystyrene, polyethylene terephthalate, stopper fragments, and potentially stainless steel.
Argatroban is administered intravenously to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HIT), a dangerous reaction to heparin. It is also used during procedures to clear blocked heart arteries. Since the drug enters the bloodstream directly, any particles pose severe risks.
The recalled batches fall under two NDC codes: 42023-182-01 and 42023-182-89. Twenty lots carry the first code, with expiration dates spanning from October 2026 through September 2027. The remaining two lots, under the second code, expire in October 2026 and August 2027. The complete list of affected batches is available through the FDA.
Hospitals and distributors nationwide must halt use of these lots immediately and return all affected stock via Inmar, Inc. The company provides contact details for recall inquiries: 1-855-648-7909 or [email protected].
Foreign particles in injectable medications carry serious dangers. The recall notice states that using the affected product presents a high likelihood of life-threatening outcomes, including pulmonary emboli, vascular blockages, and vein inflammation. Patients with HIT already face raised clot risks, making this recall particularly urgent.
Life-threatening risks demand urgent removal
Healthcare facilities must quickly identify and remove recalled batches while ensuring patients receive proper treatment. The FDA has yet to assign a formal recall classification, though updates may appear in its database. As of now, no adverse events have been reported to Par Health related to this issue.
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Since Argatroban is hospital-exclusive, patients need not take action unless they suspect the drug was used during a procedure since late 2024. Symptoms like sudden breathlessness, chest pain, or limb swelling warrant medical evaluation, though these may stem from unrelated causes. The FDA’s MedWatch program allows clinicians and patients to report quality concerns or side effects.
This recall follows a series of particle-related issues in injectable drugs in 2026, including a recent American Regent recall for glass fragments. Argatroban itself faced a 2011 recall by Eagle Pharmaceuticals for visible particles in a different formulation.
How hospitals must verify and dispose of recalled lots
Hospitals should cross-reference their inventory with the recalled lot numbers and contact Inmar for disposal instructions. Par Health’s customer service line—1-800-828-9393—handles medical inquiries and product complaints.
The recall notice details expiration dates for each of the 22 batches. Under NDC 42023-182-01, lot 83449 expires in October 2026, while lot 82682 expires in November 2026. Lots 86714, 87302, and 87560 all expire in February 2027. Lots 87753 and 88401 expire in March 2027, and lots 88614 and 88836 expire in April 2027. The remaining lots under this code include 90220 (May 2027), 91216 and 91219 (June 2027), and 92004 and 92006 (July 2027). Lots 92009, 92596, 92782, 93107, and 93329 expire in August 2027, with lot 93890 set for September 2027. The second NDC, 42023-182-89, covers lot 84193 (October 2026) and lot 92880 (August 2027).
Families with concerns should ask their physician or hospital pharmacist whether Argatroban from a recalled lot was used during recent treatment. The MedWatch program remains the primary channel for reporting suspected adverse events. Par Health’s customer service operates Monday through Thursday from 9 a.m. to 8 p.m. ET and Friday from 9 a.m. to 6 p.m. ET for medical inquiries.
