FDA Drug Recalls

Recalls / Active ingredient / Fentanyl Citrate

Fentanyl Citrate

5 FDA drug recalls involving the active ingredient “Fentanyl Citrate.

DateClassProductFirm
2020-07-20Class IIFentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, DistribuPfizer Inc.
2015-05-13Class IIIFentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use PreservativeWest-Ward Pharmaceutical Corp.
2015-02-16Class IIIFentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For IntravWest-Ward Pharmaceutical Corporation
2014-12-03Class IIFentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25Hospira Inc.
2014-06-27Class IIFentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, RHospira Inc.