CLASS III ONGOING Drug recall · Reported 4 Mar 2026 · FDA Enforcement Report
Eptifibatide Injection, 75 mg/ vial recalled
Slate Run Pharmaceuticals is recalling Eptifibatide Injection, 75 mg/ vial for weight-adjusted bolus dosing, mL Single-dose Vial, distributed nationwide in the US. The recall was initiated on 12 Feb 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0343-2026
- FDA event ID
- 98416
- Recalling firm
- Slate Run Pharmaceuticals, Columbus, OH
- Brand
- Eptifibatide
- Manufacturer
- Slate Run Pharmaceuticals, LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 12 Feb 2026
- FDA classified
- 23 Feb 2026
- Reported
- 4 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Feb 2026 | Recall initiated by company | |
| 23 Feb 2026 | Classified by FDA | +11 days |
| 4 Mar 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the USA.
Questions about this recall
Why was it 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.
Which lots are affected?
All lots within expiry
Where was it sold?
Nationwide within the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Slate Run Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets 30 mg recalled | Slate Run Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets 60 mg recalled | Slate Run Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Eptifibatide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eptifibatide injection 20mg/ (2mg/mL) Single-Dose Vial recalledEptifibatide | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, a) 20 mg/ (2 mg/mL) Single Use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |