Direct Rx recalls
FDA enforcement reports naming Direct Rx as the recalling firm.
- Recall reports
- 37
- Class I (serious)
- 0
- Most recent report
- Jul 1, 2026
- Jul 1, 2026DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 CapsDrug · Direct RxCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitClass II
- Aug 13, 2025Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-…Drug · Direct RxCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.Class II
- Aug 13, 2025Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Di…Drug · Direct RxCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.Class II
- Apr 23, 2025CIPROFLOXACIN OPHTH SOLUTION, 0Drug · Direct RxDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottleClass II
- Nov 13, 2024Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Pac…Drug · Direct RxFailed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.Class II
- Apr 12, 2023Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottleDrug · Direct RxCGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.Class II
- Apr 12, 2023Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct…Drug · Direct RxCGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.Class II
- Apr 12, 2023Alprazolam C-IV, 0Drug · Direct RxCGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.Class II
- Apr 5, 2023Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottleDrug · Direct RxcGMP deviationsClass II
- Apr 5, 2023Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottleDrug · Direct RxcGMP deviationsClass II
- Ropinirole, USP, 0
- Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle
- Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle
- Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle
- Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle
- Moxifloxacin Ophthalmic Solution, 0
- Triamcinolone Acetonide cream, 0
- Losartan Pot
- Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By…
- Losartan Pot/HCTZ 50/12
- Losartan Pot/HCTZ 100/12
- Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direc…
- Diclofenac Sodium Topical Solution 1
- Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist
- Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist
- Moxifloxacin Ophthalmic Solution USP 0
- Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Da…
- Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and…
- Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville,…
- Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60)
- Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Daw…
- Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dire…
- Losartan Pot/HCTZ 50/12
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