HIGHFDA DRUG

Eptifibatide Injection Recalled Over Labeling Error

Slate Run Pharmaceuticals recalled Eptifibatide Injection on February 12, 2026. The recall affects all lots of the 75 mg/100 mL vial due to incorrect dosing information. Healthcare providers and consumers must stop using the product immediately.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
February 12, 2026
Status
ACTIVE
Severity
6/10

Quick Facts at a Glance

Recall Date
February 12, 2026
Hazard Level
HIGH
Brands
EPTIFIBATIDE, Slate Run Pharmaceuticals, LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
EPTIFIBATIDE, Slate Run Pharmaceuticals, LLC
Product type
Eptifibatide Injection
Model numbers
All lots within expiry
UPC codes
70436-026, 70436-027, 70436-162, 70436-163, 70436-026-80, 70436-027-80, 70436-162-80, 70436-163-80
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 12, 2026

  2. Reported by FDA DRUG

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Slate Run Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

About This Product

Eptifibatide Injection is a medication used in healthcare settings as an anticoagulant. It is typically administered intravenously during procedures to prevent blood clots.

Why This Is Dangerous

The product's labeling error can lead to incorrect dosing, which may affect patient safety during treatment. Administering a bolus dose instead of an infusion can lead to serious complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the product immediately, which could impact treatment plans for patients. The urgency to correct the labeling can lead to temporary disruptions in care.

Practical Guidance

How to identify if yours is affected

  1. Check the product packaging for NDC numbers.
  2. Verify if the vial states 'bolus dosing' instead of 'infusion.'
  3. Look for expiration dates on the product.

Where to find product info

The NDC numbers can be found on the carton label or the product packaging itself.

What timeline to expect

Expect a timeline of 4-6 weeks for refund processing after returning the product.

If the manufacturer is unresponsive

  • Contact the FDA for further assistance.
  • Document your communication attempts with Slate Run Pharmaceuticals.
  • File a complaint with the FDA if necessary.

How to prevent similar issues

  • Always check product labels before use.
  • Verify dosing instructions with a healthcare provider.
  • Stay informed about recalls through FDA notifications.

Documentation advice

Keep records of your purchase, correspondence with the manufacturer, and photographs of the product for your records.

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Key Facts

  • Recall date: February 12, 2026
  • Reported date: March 4, 2026
  • Class III recall status
  • Nationwide distribution in the USA

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
All lots within expiry
UPC Codes
70436-026
70436-027
70436-162
+5 more
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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