FDA Drugs recall ·
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0083-2027
- Date
- (initiated October 13, 2026)
- Company / brand
- Par Health USA, LLC
870 Parkdale Rd, Rochester, MI, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1944 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
Distribution
Nationwide within the United States
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0083-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.