Class IIIOngoing

Eptifibatide Injection recall

FDA recall D-0343-2026 · initiated Feb 12, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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.

Details

Product: Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Recalling company: Slate Run Pharma
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the USA.
Initiated: Feb 12, 2026
FDA report date: Mar 4, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0343-2026 ↗

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