FDA Recall D-0343-2026

Slate Run Pharmaceuticals · Columbus, OH

Class III Ongoing 91 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

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

Lot / code: All lots within expiry

Quantity: N/A

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.

Recall record

Recall number: D-0343-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA.
Recall initiated: 2026-02-12
Classified by FDA Center: 2026-02-23
FDA published: 2026-03-04
Recalling firm: Slate Run Pharmaceuticals
Firm location: Columbus, OH

Drug identification

Brand name(s): EPTIFIBATIDE
Generic name(s): EPTIFIBATIDE
Manufacturer(s): Slate Run Pharmaceuticals, LLC
NDC(s): 70436-026, 70436-027, 70436-162, 70436-163
Route(s): INTRAVENOUS

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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