Par Health recalls argatroban injection lots over particulate contamination

Par Health USA, LLC initiated a recall of argatroban injection products on October 13, 2026, after discovering foreign particulate matter in the solution. The U.S. Food and Drug Administration classified the actions as Class I, its most serious recall category, on October 26, 2026, with both recalls reported on October 28, 2026 and listed as ongoing.

The contamination was identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material found in the product solution¹.

The larger of the two recalls, D-0082-2027, covers 18,991 vials of Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), in 2.5 mL single dose vials¹. The product was manufactured for Endo USA of Malvern, Pennsylvania and distributed by Par Pharmaceutical of Chestnut Ridge, New York, under NDC 42023-182-01¹. Affected lots include numbers 83449, 82682, 86714, 87302, 87560, 87753, 88401, 88614, 88836, 90220, 91216, 91219, 92004, 92006, 92009, 92596, 92782, 93107, 93329 and 93890, with expiration dates ranging from October 2026 through September 2027¹.

A second, smaller recall, D-0083-2027, covers 1,944 vials of the same argatroban injection formulation, distributed by Par Pharmaceutical of Cranbury, New Jersey, under NDC 42023-182-89². That recall involves lots 84193, expiring October 2026, and 92880, expiring August 2027².

Both recalls were voluntary and firm initiated, with the recall originating from Par Health USA's facility at 870 Parkdale Rd in Rochester, Michigan, and distribution occurring nationwide within the United States according to both FDA enforcement records. The company notified the FDA via press release in both cases.