Argatroban Injection
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Recall notice
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
We’re still writing up this recall
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/1927660-par-health-usa-llc-recalls-argatroban-injection-usp-250-mg · Recall date October 13, 2026 · FDA enforcement record: FDA #D-0082-2027
Cite this page
“Argatroban Injection.” GovInfoNow, recall dated October 13, 2026. https://govinfonow.com/recall/1927660-par-health-usa-llc-recalls-argatroban-injection-usp-250-mg. Based on FDA recall #D-0082-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0082-2027%22&limit=1).
How to tell if you have this one
- Brand
Par Health USA, LLC- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0082-2027 | 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 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.; 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. | 18,991 vials |
| 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 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.; Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027. | 1944 vials |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0082-2027 (October 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0082-2027 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.