Par Health USA, LLC recalls Argatroban Injection
- Recalling company
- Par Health USA, LLC
- 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, Cranbury, NJ 08512, NDC 42023-182-89.
- Reason
- Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Oct 13, 2026
- Reported
- Oct 28, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 1944 vials
- Lot / codes
- Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
- Company location
- Rochester, MI
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0083-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0083-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.