FDA Drug Recalls

Recalls / Active ingredient / Fluconazole

Fluconazole

10 FDA drug recalls involving the active ingredient “Fluconazole”.

DateClassProductFirm
2017-05-15Class IIFluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, BaxterBaxter Healthcare Corporation
2017-01-05Class IIFluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's LaboratorieThe Harvard Drug Group
2017-01-05Class IIFluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's LaboratorieThe Harvard Drug Group
2016-12-28Class IIFlucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Dr. Reddy's Laboratories, Inc.
2016-12-28Class IIFlucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 5Dr. Reddy's Laboratories, Inc.
2016-12-28Class IIFlucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, RDr. Reddy's Laboratories, Inc.
2016-12-28Class IIFlucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Dr. Reddy's Laboratories, Inc.
2016-12-06Class IIFluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, BaxterBaxter Healthcare Corporation
2014-12-23Class IIFluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10Baxter Healthcare Corp.
2014-01-29Class IIGREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, DistPfizer Inc.