Par Health recalls 22 lots of argatroban injection over particles
The nationwide recall reaches hospital users. The company reports no related adverse events, a statement that does not establish the absence of harm.
Original-source briefing · AI-written · Edited by Codex
Source event: 2026-10-13. Published: 2026-10-14T17:32:57.584Z. Updated: 2026-10-14T17:32:57.584Z.
What happened
Primary-source statement · Par Health announced a nationwide recall of 22 lots of argatroban injection on October 13; the FDA posted the company notice on October 14. The recall covers 250 mg/2.5 mL (100 mg/mL) vials distributed under Par Pharmaceutical or Endo USA labeling. Par says particles found in certain lots included cellulose, plastics, stopper material and possibly stainless steel. The company says the affected lots reached wholesalers and hospitals between December 30, 2024, and May 5, 2026. [FDA]
Why it matters
Primary-source statement · The notice describes argatroban as an anticoagulant used for certain adults with heparin-induced thrombocytopenia. Par warns that administering contaminated solution could cause life-threatening complications, including blocked blood vessels and vein inflammation. Its recall reaches hospital users, and it directs hospital pharmacies and wholesalers to stop using and distributing affected stock and arrange returns. The original notice lists all 22 lots under NDCs 42023-182-01 and 42023-182-89; the recall is not described as covering every argatroban product. [FDA]
What remains unknown
Evidence limits · Par said it had received no related adverse-event reports as of its October 13 announcement. That does not establish that no patient was exposed or harmed. The notice does not quantify affected vials, identify how the particles entered the product or establish the extent of remaining hospital inventory. FDA hosting and the company newsroom repeat one originating account, not independent clinical confirmation. This report summarizes an institutional recall; it does not recommend an individual treatment change. [FDA]
This institutional medication-recall report applies across adult patient groups. Product and lot details belong to the original notice; this is not personal medical advice.
Read the infographic as text
SCOPE. 22 lots · Par Pharmaceutical / Endo USA labels
STRENGTH. 250 mg / 2.5 mL (100 mg/mL)
NDCs. 42023-182-01 / 42023-182-89
DISTRIBUTION. Wholesalers and hospitals · nationwide
COMPANY INSTRUCTION. Hospital pharmacies and wholesalers: stop use and distribution of affected stock and arrange returns.
Evidence limit. The original lists the exact 22 lots. This is an institutional recall, not advice to change an individual treatment.
Graphic sources: FDA
The developing record.
Earlier entries preserve what was published at that time; later entries may revise them.
2026-10-14T17:32:57.584Z · Initial reviewed report of the October 13 company recall, posted by FDA on October 14, with affected-lot and evidence limits.
Par Health recalls 22 lots of argatroban injection over particles
The nationwide recall reaches hospital users. The company reports no related adverse events, a statement that does not establish the absence of harm.
What happened
Par Health announced a nationwide recall of 22 lots of argatroban injection on October 13; the FDA posted the company notice on October 14. The recall covers 250 mg/2.5 mL (100 mg/mL) vials distributed under Par Pharmaceutical or Endo USA labeling. Par says particles found in certain lots included cellulose, plastics, stopper material and possibly stainless steel. The company says the affected lots reached wholesalers and hospitals between December 30, 2024, and May 5, 2026. [FDA]
Why it matters
The notice describes argatroban as an anticoagulant used for certain adults with heparin-induced thrombocytopenia. Par warns that administering contaminated solution could cause life-threatening complications, including blocked blood vessels and vein inflammation. Its recall reaches hospital users, and it directs hospital pharmacies and wholesalers to stop using and distributing affected stock and arrange returns. The original notice lists all 22 lots under NDCs 42023-182-01 and 42023-182-89; the recall is not described as covering every argatroban product. [FDA]
What remains unknown
Par said it had received no related adverse-event reports as of its October 13 announcement. That does not establish that no patient was exposed or harmed. The notice does not quantify affected vials, identify how the particles entered the product or establish the extent of remaining hospital inventory. FDA hosting and the company newsroom repeat one originating account, not independent clinical confirmation. This report summarizes an institutional recall; it does not recommend an individual treatment change. [FDA]
Original sources
Par Health: nationwide argatroban injection recall, FDA-hosted company announcement · Issuer: Par Health USA, LLC · 2026-10-14
Corrections
No corrections recorded.