FDA recall, , Low risk
Slate Run Eptifibatide Injection
Eptifibatide Injection's carton labeling states 75 mg/100 mL vial for weight-adjusted bolus dosing, but the approved statement is for weight-adjusted infusion.
Summary by Recall Canary from the FDA notice
What happened
Slate Run Pharmaceuticals, based in Columbus, Ohio, began a recall of Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, on February 12, 2026, according to the FDA.
The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing, but the approved statement is 75 mg/100 mL vial for weight-adjusted infusion. The product was distributed nationwide within the USA, added to the FDA's Enforcement Report on February 23, 2026, and listed in the FDA's weekly enforcement report on March 4, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
Eptifibatide Injection
- NDC
- 70436-027-80
- 70436-163-80
- Lot code
- All lots within expiry
Recall details
- Company began the recall
- Sold in
Nationwide within the USA.
- Company
- Slate Run PharmaceuticalsColumbus, Ohio
- Hazard
- Labeling error
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98416
- Recall number
- D-0343-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
