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Verified · FDAClass III — Low RiskMedications

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing Recall 2026

EPTIFIBATIDEIssued February 12, 2026Updated Reviewed by the Recall Watch editorial team

EPTIFIBATIDE 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 Econ — recalled per FDA on 2/12/2026. Reason: 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..

Agency
FDA
Issued
Feb 12, 2026
Brand
EPTIFIBATIDE
Distribution
1 states
Lots affected
1
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued February 12, 2026 · Last synced Nov 1, 2026

What's recalled

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

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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.

Affected products & lot numbers
1 lot called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
All lots within expiry
Where was it sold
1 state

Nationwide within the USA.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the EPTIFIBATIDE recall still active?

Yes, this recall is currently active as of February 12, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: All lots within expiry. Check the label on your product.

What should I do if I have the recalled EPTIFIBATIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.