FDA Drug Recalls

Recalls / Active ingredient / Epinephrine Bitartrate

Epinephrine Bitartrate

12 FDA drug recalls involving the active ingredient “Epinephrine Bitartrate.

DateClassProductFirm
2025-10-31Class IILidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a cartonNovocol Pharmaceutical of Canada, Inc.
2025-10-31Class II2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a caNovocol Pharmaceutical of Canada, Inc.
2022-11-22Class IISensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0Fresenius Kabi USA, LLC
2022-11-22Class IISensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%Fresenius Kabi USA, LLC
2022-11-22Class IISensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%,Fresenius Kabi USA, LLC
2022-04-13Class IIXylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 2Mckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIXylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63Mckesson Medical-Surgical Inc. Corporate Office
2021-06-25Class IIXylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (1Fresenius Kabi USA LLC
2020-12-10Class IISensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Fresenius Kabi USA, LLC
2019-05-02Class IIArticaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Septodont Inc.
2016-04-25Class IISensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi Fresenius Kabi USA, LLC
2013-08-14Class IILidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration OnlNovocol Pharmaceutical of Canada