FDAFDA recall D-0082-2027 · Oct 28, 2026
Par Health USA, LLC: Argatroban Injection recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Distribution
- Nationwide within the United States
- Recalling firm
- Par Health USA, LLC, Rochester, MI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-10-13
Source: openFDA enforcement record D-0082-2027 · search recall number D-0082-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Nov 3, 2026, 1:33 AM EST. The agency notice is the final word.