FDA Recalls Argatroban Injection Vials Due to Particulate Matter
Par Health USA is recalling 18,991 vials of Argatroban Injection because they contain particulate matter. The affected vials were distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source identifies particulate matter (cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material) in an intravenous drug, which is classified as an FDA Class I recall. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Par Health USA, LLC is recalling 18,991 vials of Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial. The recall was initiated because particulate matter was identified in the product solution. The particulate matter was identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material.
The affected product is a prescription-only intravenous medication manufactured for Endo USA and distributed by Par Pharmaceutical. The recall covers specific lots with expiration dates ranging from October 2026 to September 2027. The product was distributed nationwide within the United States.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement. The FDA classifies this recall as Class I.
The recalled product
- Product
- ARGATROBAN (ARGATROBAN)
- Brand
- ARGATROBAN
- Manufacturer
- Par Health USA, LLC
- Category
- Drug — Injection
- Affected units
- 18,991
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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