FDA Drug Recalls

Recalls / Firms / Direct Rx

Direct Rx

36 FDA drug recalls on record.

DateClassDrugStatus
2025-03-07Class IIDuloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30,Ongoing
2025-03-07Class IIDuloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: DirecOngoing
2025-01-31Class IICIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Ongoing
2024-08-09Class IIIbuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, PackagOngoing
2023-03-22Class IIAlprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Ongoing
2023-03-22Class IIAlprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct RxOngoing
2023-03-22Class IIAlprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs perOngoing
2023-03-13Class IISimvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688Terminated
2023-03-13Class IISimvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, PackagTerminated
2023-03-13Class IIGlimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-Terminated
2023-03-13Class IISimvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Terminated
2023-03-13Class IIGlimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-Terminated
2023-03-13Class IISimvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446Terminated
2023-03-13Class IIFinasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90;Terminated
2023-03-13Class IIRopinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Terminated
2023-03-13Class IIMontelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, Terminated
2023-03-13Class IIGlimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-Terminated
2023-03-13Class IIRopinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-3Terminated
2022-11-02Class IIMoxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: DirectTerminated
2022-09-12Class IITriamcinolone AcetonideCompleted
2022-05-13Class IIZonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: DTerminated
2022-05-11Class IILosartan Potassium And HydrochlorothiazideTerminated
2022-05-11Class IILosartan Potassium And HydrochlorothiazideTerminated
2022-05-11Class IILosartan Potassium And HydrochlorothiazideTerminated
2022-05-05Class IILosartan Potassium And HydrochlorothiazideTerminated
2022-03-04Class IIAlprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut RidgTerminated
2022-03-04Class IIAlprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut RidTerminated
2022-02-17Class IIMoxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx DaTerminated
2021-12-07Class IIDiclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: DirTerminated
2021-09-14Class IIZonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx DawsoTerminated
2021-03-02Class IINortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and DisTerminated
2020-10-12Class IIMetformin Hydrochloride Extended ReleaseTerminated
2020-01-15Class IIRanitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx DawsonTerminated
2020-01-15Class IIRanitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottleTerminated
2019-04-30Class IILosartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Terminated
2019-03-12Class IILosartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GTerminated