Par Health recalls Argatroban injection over particulate contamination

Overview

Updated Oct 14

Par Health pulled 22 lots of its Argatroban Injection off the market after finding bits of cellulose, plastic, and possible stainless steel in the anticoagulant. The injectable treats blood clots in patients with heparin-induced thrombocytopenia, a rare immune reaction to the common blood thinner.

The FDA's enforcement report for the recall, assigned number D-0082-2027, was published October 28. The Recall Desk, which tracks those filings, lists 18,991 vials in the recall. It is the third particulate-related recall Par Health has issued since September: Brevital Sodium on October 8 and Dexmedetomidine HCl on September 18.

Why it matters

Injected particulate matter can block blood vessels and damage organs. Three particulate recalls since September at one manufacturer point to a systemic contamination problem.

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Key Indicators

22 lots

Lots of Argatroban Injection recalled

Recalled to hospital and user level nationwide.

Adverse events reported

Par Health reports no injuries tied to the recalled lots as of the recall date.

18,991

Vials in the recall

Figure listed by The Recall Desk, which tracks FDA enforcement reports.

491 days

Window for recalled lot distribution

Lots reached wholesalers and hospitals from December 30, 2024 to May 5, 2026.

Par Health particulate recalls since September

Dexmedetomidine HCl recalled September 18; Brevital Sodium October 8; Argatroban Injection October 13.

Voices

Curated perspectives — historical figures and your fellow readers.

Organizations Involved

Par Health

Pharmaceutical manufacturer

Recalling 22 lots of Argatroban Injection

Michigan-based pharmaceutical manufacturer recalling 22 lots of Argatroban Injection for particulate contamination.

Inmar, Inc.

Returns and recall logistics company

Handling return of recalled Par Health products

Company coordinating the return of recalled Par Health inventory.

U.S. Food and Drug Administration

Federal regulator

Listed the Argatroban recall in its enforcement database on October 28, 2026

U.S. federal agency responsible for drug safety; published the Brevital, Dexmedetomidine and Argatroban recall notices.

Timeline

September 2026 October 2026

4 events Latest: October 28th, 2026 · 2 weeks ago

Tap a bar to jump to that date

October 2026
FDA enforcement report lists Argatroban recall
Latest Regulatory

The FDA's enforcement report assigned the recall number D-0082-2027. The Recall Desk, which tracks those reports, lists 18,991 vials in the recall.
October 28th, 2026
Par Health recalls 22 lots of Argatroban Injection
Recall

The anticoagulant contained cellulose, polyethylene terephthalate, stopper material, and possibly stainless steel. No adverse events reported.
October 13th, 2026
Par Health recalls two lots of Brevital Sodium
Recall

The company pulled the anesthetic for cellulose particulate matter. This was the first recall in the five-day sequence.
October 8th, 2026
September 2026
Par Health recalls two lots of Dexmedetomidine HCl injection
Recall

The company pulled the product for particulate matter identified as cellulose or stopper material. No adverse events reported.
September 18th, 2026

Scenarios

No adverse events tied to recalled Argatroban lots

Possible Resolves by Q2 2027

Discussed by: Par Health's recall statement; FDA adverse event surveillance

Par Health says no injuries have been reported to date. If none surface in the coming months, this recall closes as a contained quality lapse and the company resumes normal operations.

FDA escalates scrutiny of Par Health

Possible Resolves by Jan 31, 2027

Discussed by: Fierce Pharma coverage of the recall pattern

Repeated contamination events typically draw an FDA inspection. If inspectors find problems at Par Health facilities, the agency could issue a Form 483 report, a warning letter, or a consent decree requiring manufacturing changes.

More Par Health recalls follow

Possible Resolves by Apr 30, 2027

Discussed by: Fierce Pharma

The Argatroban recall came five days after the Brevital one, plus a string of industry-wide particulate recalls over the past year. If the same contamination shows up in other Par Health products, additional lots would be pulled.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

September 2012

New England Compounding Center fungal meningitis outbreak (2012)

A Massachusetts compounding pharmacy shipped steroid injections contaminated with fungus. At least 753 patients across 20 states developed fungal meningitis; 64 died.

Then

The company recalled every product, filed for bankruptcy, and federal prosecutors charged fourteen people, including the owner.

Now

Congress passed the Drug Quality and Security Act in 2013, expanding FDA authority over compounding pharmacies.

Why this matters now

The worst-case outcome for contaminated injectables — a reminder of why particulate or microbial contamination in sterile drugs is treated as a serious threat.

January 2010

McNeil Consumer Healthcare Tylenol recalls (2010)

McNeil recalled millions of bottles of Tylenol and other products after quality lapses at its Fort Washington, Pennsylvania plant, including metal particles found in some tablets.

Then

Production halted for over a year and McNeil lost significant share of the painkiller market. The company signed a consent decree with the FDA in 2011.

Now

The case became a standard example of how recurring quality lapses at one manufacturer draw escalating FDA enforcement.

Why this matters now

Shows that repeated contamination events at a single manufacturer typically push regulators toward formal enforcement action.