CLASS I ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report
Argatroban Injection, USP, 250 mg/ (100 mg/mL) x Dose Vial recalled
Par Health USA is recalling Argatroban Injection, USP, 250 mg/ (100 mg/mL) x Dose Vial, distributed nationwide in the US. The recall was initiated on 13 Oct 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0083-2027
- FDA event ID
- 100072
- Recalling firm
- Par Health USA, Rochester, MI
- Brand
- Argatroban
- Manufacturer
- Par Health USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Oct 2026
- FDA classified
- 26 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Oct 2026 | Recall initiated by company | |
| 26 Oct 2026 | Classified by FDA | +13 days |
| 28 Oct 2026 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Which lots are affected?
Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 100072This product is part of a recall event; the main page for the event is Argatroban Injection, USP, 250 mg/ (100 mg/mL) x Dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Argatroban Injection, USP, 250 mg/ (100 mg/mL) x Dose Vial recalledArgatroban | Par Health USA | Particulate Matter | Nationwide |
More recalls from Par Health USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Argatroban Injection, USP, 250 mg/ (100 mg/mL) x Dose Vial recalledArgatroban | Par Health USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection 0.3 mg/mL recalledBuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
Other Argatroban recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Argatroban Injection, USP, 250 mg/ (100 mg/mL) x Dose Vial recalledArgatroban | Par Health USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use Vial recalled | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc. A Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |