Yes — there is an active recall. 2 ongoing FDA recalls mention Eptifibatide (6 total). Check the affected lots below.
Most common reason: Impurity / degradation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Eptifibatide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
CGMP Deviations
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