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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Eptifibatide Injection Recalled for Labeling Error

Agency Publication Date: February 23, 2026
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Summary

Slate Run Pharmaceuticals is recalling all unexpired lots of Eptifibatide Injection (75 mg/100 mL) because the carton incorrectly identifies the medication for 'bolus dosing' (a rapid, one-time dose). The approved use for this specific concentration is actually for a 'weight-adjusted infusion' (a slow, continuous drip). This labeling error could lead to dosing mistakes in a clinical setting.

Risk

If a healthcare provider follows the incorrect carton label, a patient could receive the wrong dose or administration rate of this blood-thinning medication, which may lead to treatment complications. No injuries or adverse events have been reported to date.

What You Should Do

  1. Stop using the recalled product. Contact Slate Run Pharmaceuticals or your distributor to arrange return.
  2. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Eptifibatide Injection, 75 mg/100 mL vial
Variants: 75 mg/100 mL, Single-dose Vial, For Intravenous Use Only
NDC:
70436-027-80
70436-163-80

All lots within expiry are affected. Carton incorrectly states 'for weight-adjusted bolus dosing' instead of 'for weight-adjusted infusion'.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98416
Status: Active
Manufacturer: Slate Run Pharmaceuticals
Sold By: Wholesalers; Hospitals; Clinics
Manufactured In: China, United States
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.