Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA,…
Par Health USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Par Health USA, LLC · 870 Parkdale Rd · Rochester, MI · 48307-1740
Is this the product you have?
- Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only
- Manufactured forEndo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only
- Distributed byPar Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01
- Lot codes and dates
- Lot #: 83449
- Exp Date
10/202682682
- Exp Date
11/2026867148730287560
- Exp Date
02/20278775388401
- Exp Date
03/20278861488836
- Exp Date
04/202790220
- Exp Date
05/20279121691219
- Exp Date
06/20279200492006
- Exp Date
07/20279200992596927829310793329
- Exp Date
08/202793890
- Exp Date09/2027
- Amount recalled
- 18,991 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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