Direct Rx recalls

Direct Rx has 37 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 1 Jul 2026. 8 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls37since 2020
Last 12 months1reported
Class I00% of total
Ongoing8latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 37 100%Class III 0 0%

By year

Ongoing direct rx recalls

8 active

All direct rx recalls, newest first

37 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDuloxetine D/R, a) 30 mg recalled by Direct RxDirect RxNitrosamine ImpurityNationwide
DrugCLASS IIDuloxetine D/R, 30 mg, 30 Caps recalled by Direct RxDirect RxNitrosamine ImpurityNationwide
DrugCLASS IIDuloxetine D/R, 20 mg, 30 Caps recalled by Direct RxDirect RxNitrosamine ImpurityNationwide
DrugCLASS IICiprofloxacin Ophth Solution recalled by Direct RxDirect RxPackaging Defects5 states
DrugCLASS IIIbuprofen 800mg, Generic for: Motrin, Each tablet contains recalledDirect RxPotency & AssayNationwide
DrugCLASS IIAlprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAlprazolam C-IV, 2 mg, 60 Tabs recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAlprazolam C-IV, 1 mg recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IISimvastatin recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIMontelukast Sodium Tablets recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIFinasteride recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IISimvastatin recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIRopinirole recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIGlimepiride recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIGlimepiride recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIRopinirole recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IISimvastatin, USP, 40 mg recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IISimvastatin recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIGlimepiride recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIMoxifloxacin Ophthalmic Solution recalled by Direct RxDirect RxPotency & AssayFL
DrugCLASS IITriamcinolone Acetonide cream, 0.1% tube recalled by Direct RxTriamcinolone AcetonideDirect RxManufacturing (CGMP) DeviationsGA, ID
DrugCLASS IILosartan Pot./HCTZ 100/12.5 mg Packaged recalled by Direct RxLosartan Potassium And HydrochlorothiazideDirect RxPotency & Assay4 states
DrugCLASS IILosartan Pot/HCTZ 100/25 mg 90 Tabs recalled by Direct RxLosartan Potassium And HydrochlorothiazideDirect RxPotency & AssayFL
DrugCLASS IILosartan Pot/HCTZ 50/12.5 mg 90 Tabs recalled by Direct RxLosartan Potassium And HydrochlorothiazideDirect RxPotency & AssayFL
DrugCLASS IILosartan Pot/HCTZ 100/12.5 mg 90 Tabs recalled by Direct RxLosartan Potassium And HydrochlorothiazideDirect RxPotency & AssayFL
DrugCLASS IIZonisamide Capsules USP, 100 mg recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDiclofenac Sodium Topical Solution recalled by Direct RxDirect RxPackaging DefectsNationwide
DrugCLASS IIAlprazolam C-IV 2 mg recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsFL, GA, LA
DrugCLASS IIAlprazolam C-IV 1 mg recalled by Direct RxDirect RxManufacturing (CGMP) DeviationsFL, GA, LA
DrugCLASS IIMoxifloxacin Ophthalmic Solution USP 0.5%, Packaged recalledDirect RxPotency & AssayFL

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.