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 Pharmaceutica

FDA recall notice · announced October 28, 2026 · Par Health

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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, Chestnut Ridge, NY 10977, NDC 42023-182-01.

Reason for recall

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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027.
Quantity: 18,991 vials
Status: Ongoing
Products in this recall event:
- 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 Sing (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 Singl (D-0082-2027)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.