Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Is Argatroban recalled?
Not under an active recall.
Argatroban was recalled 4 times in the past — all now closed. Most recent: Aug 28, 2018.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Argatroban. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Argatroban recalls on record
none so far in 2026; 4 on record, newest first
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class II · Moderate risk
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
CGMP Deviations
Class I · High risk
Argatroban Injection 50 mg per 50ml
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
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