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Low risk Drugs & MedicationsClass III

Eptifibatide Injection Recall - Labeling Error

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Ma

Updated February 12, 2026

Eptifibatide Injection 75 mg/100 mL vials distributed by Slate Run Pharmaceuticals have incorrect labeling on the carton. The label says "for weight-adjusted bolus dosing" when it should say "for weight-adjusted infusion," which could cause confusion about the correct method of administration.

Is the Slate Run Pharmaceuticals recalled? Yes. This product was recalled by FDA on February 12, 2026. Details below.

What is recalled

Eptifibatide Injection, 75 mg/100 mL vials, 1x100 mL Single-dose Vial, For Intravenous Use Only. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80. Manufactured by Hainan Poly Pharm. Co., Ltd., Haikou, Hainan Province, China. Distributed by Slate Run Pharmaceuticals, LLC, Columbus, Ohio.

Am I affected

You're affected if you have Eptifibatide Injection 75 mg/100 mL vials with NDC label 70436-027-80 or 70436-163-80 dispensed from Slate Run Pharmaceuticals.

What to do right now

Contact Slate Run Pharmaceuticals or your pharmacy or healthcare provider immediately if you have this product to confirm the correct administration method and ensure proper dosing.

The hazard

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.

Brands affected

Slate Run Pharmaceuticals
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0343-2026
Classification
Class III
Recalled
February 12, 2026
Read the official notice

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