FDA Drug Recalls

Recalls / Firms / AVKARE Inc.

AVKARE Inc.

33 FDA drug recalls on record1 Class I.

DateClassDrugStatus
2022-07-20Class IIILamotrigineTerminated
2021-06-09Class IIIPhytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Terminated
2020-12-07Class ITraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: Terminated
2020-12-07Class IISildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE PulaskiTerminated
2020-10-30Class IIMesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx OnlyTerminated
2020-06-04Class IIMetformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-1Terminated
2020-06-04Class IIMetformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90Terminated
2020-05-28Class IIILamotrigineTerminated
2020-01-07Class IIDutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, ManufactuTerminated
2019-11-14Class IIAVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 3Terminated
2019-11-14Class IIAVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, Terminated
2019-10-17Class IIAVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC Terminated
2019-10-17Class IIAVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC Terminated
2019-08-28Class IIAVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottleTerminated
2019-04-24Class IILosartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Ongoing
2019-04-24Class IILosartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Ongoing
2019-04-03Class IIITelmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKTerminated
2019-03-05Class IILosartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, ManufactuTerminated
2019-03-05Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) UnTerminated
2019-03-05Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) UTerminated
2019-03-01Class IIIOxybutynin ChlorideTerminated
2018-11-20Class IIGerm Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill Terminated
2018-08-14Class IIValsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose ManufactTerminated
2018-08-14Class IIValsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 ManufacTerminated
2018-08-14Class IIValsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 ManufactTerminated
2018-08-14Class IIValsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 ManufactTerminated
2018-03-30Class IIAmantadine HclTerminated
2018-01-03Class IILovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured fTerminated
2017-10-06Class IIDuloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton,Terminated
2017-07-19Class IIIVoriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured foTerminated
2017-02-15Class IIFamciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, ManufacturedTerminated
2015-02-27Class IIIQuinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured forTerminated
2015-02-27Class IIIQuinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured foTerminated