The argatroban injection recall 2026 covers 22 lots of a hospital anticoagulant after particulate matter was found in some of the product. Par Health announced the voluntary nationwide recall on 13 October 2026, and the FDA posted the recall notice on 14 October. The company says the particles include cellulose, polystyrene, polyethylene terephthalate (a common plastic), stopper material and possibly stainless steel, and that it has not received any reports of adverse events related to the recall.
Argatroban is given by continuous intravenous infusion in hospitals, so the recall is aimed at wholesalers and hospital pharmacies, not at the public. Below is a lot-by-lot guide to what is affected and what the notice asks them to do.
Argatroban injection recall 2026: key takeaways
- Product: Argatroban Injection 250 mg/2.5 mL (100 mg/mL), National Drug Codes (NDCs) 42023-182-01 and 42023-182-89, sold under the Par Health and Endo USA names.
- Scope: 22 lots distributed nationwide between 30 December 2024 and 5 May 2026.
- Reason: particulate matter identified in certain lots.
- Level: hospital or user level, with wholesalers and hospitals asked to stop use and distribution immediately.
- Harm reported: none, according to the company.
What is covered by the argatroban injection recall 2026
The recalled vials hold 250 mg of argatroban in 2.5 mL of solution. According to the notice, the product was distributed by Par Pharmaceutical or Endo USA, and the current distributor is Par Health USA, LLC. Those two earlier companies are described as predecessors of Par Health USA. By our count, 20 of the 22 lots carry NDC 42023-182-01 and two carry 42023-182-89. The distribution window of about 16 months is also our calculation from the dates in the notice.
The notice does not say how the particles were identified, and it does not say which type of particle was found in which lot. It refers only to “certain lots”, so every listed lot should be treated as affected.
Argatroban injection recall 2026: lot numbers by expiry date
The list below is our grouping of the lots published in the notice, arranged by expiry date. Always check lot numbers against the original FDA notice before acting.
- October 2026: 83449 and 84193 (84193 is NDC 42023-182-89).
- November 2026: 82682.
- February 2027: 86714, 87302 and 87560.
- March 2027: 87753 and 88401.
- April 2027: 88614 and 88836.
- May 2027: 90220.
- June 2027: 91216 and 91219.
- July 2027: 92004 and 92006.
- August 2027: 92009, 92596, 92782, 93107 and 93329, plus 92880 (NDC 42023-182-89).
- September 2027: 93890.
The two earliest-expiring lots, 83449 and 84193, expire this month, which means some of the recalled stock may already be close to or past its expiry date.
Why particles in an injection are a concern
The company states that giving the recalled product has a reasonable probability of causing life-threatening adverse health consequences. The risks it names are blockage of blood vessels in the lungs (pulmonary emboli), blockage of other blood vessels that can lead to tissue death and organ damage, and inflammation of vein walls that may lead to clotting. Those are the potential consequences listed in the notice; no such event has been reported.
What the notice asks hospitals and wholesalers to do
- Immediately stop using and distributing the listed lots.
- Expect written notification from Par Health, which is arranging returns of all inventory through Inmar, Inc.
- If you passed the product on, tell your own accounts or locations that may have received it.
- Report returns questions to Inmar on 1-855-648-7909 (Monday to Friday, 9 a.m. to 5 p.m. Eastern) or rxrecalls@inmar.com.
- Report product complaints or adverse events to Par Health on 1-800-828-9393, or through FDA MedWatch online or by phone on 1-800-332-1088.
The argatroban injection recall 2026 is described as being conducted with the knowledge of the FDA. For background on the drug, a StatPearls review of argatroban describes it as a direct thrombin inhibitor, a synthetic anticoagulant used for patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant during percutaneous coronary intervention in patients with or at risk of HIT.
What patients should know
Patients do not buy this product and do not need to find lot numbers themselves. Anyone concerned about an infusion they are receiving, or have received, should speak to their care team. They should not stop any prescribed treatment on their own, because argatroban is used to prevent dangerous clotting.
Risks and caveats for the argatroban injection recall 2026
- The notice is the company’s own account, posted by the FDA; the FDA has not, in the material we reviewed, stated a risk classification.
- The cause of the contamination has not been explained.
- It is unclear how many vials remain in hospital stock and whether supply will be affected.
- The lot list in this article is our rearrangement of the notice, so verify against the source.
In our assessment, hospital pharmacies will treat this as a straightforward quarantine-and-return exercise, but the mixed list of particle types, from plastics to possible metal, makes the root cause worth watching. A single cause is less obvious than it would be for one material.
For another recall story from our archive, see our report on the Philips sleep apnea device recall, and browse more pharmaceutical news.
What to watch next in the argatroban injection recall 2026
- Any update to the lot list or an expansion of the recall.
- An explanation of how and where the particles entered the product.
- Information on availability of argatroban for hospitals.
- Any adverse-event reports submitted through MedWatch.
Frequently asked questions
What is the argatroban injection recall 2026?
A voluntary nationwide recall by Par Health of 22 lots of Argatroban Injection 250 mg/2.5 mL because of particulate matter, announced on 13 October and posted by the FDA on 14 October 2026.
Which products are affected by the argatroban injection recall 2026?
Vials with NDC 42023-182-01 or 42023-182-89 and one of the 22 lot numbers listed in the FDA notice.
Has anyone been harmed?
The company says it has not received reports of adverse events related to the recall.
What should hospitals do during the argatroban injection recall 2026?
Stop using and distributing the listed lots immediately, and return stock through Inmar as directed in the notice.
What is argatroban used for?
It is an anticoagulant used in hospitals for patients with heparin-induced thrombocytopenia, and during certain heart procedures in patients with or at risk of it.
How we reported this: we relied on the FDA’s recall notice of 14 October 2026 for Par Health’s argatroban injection, an FDA MedWatch page and a StatPearls review of argatroban. Figures labelled as ours are our own calculations. Last updated: 15 October 2026. This article is news reporting and not medical advice.