Direct Rx Recalls
37 recalls on record · October 7, 2020 to July 1, 2026 · Drugs
Recalls by year
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 1, 2026DrugsFDA
Direct Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distr
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
August 13, 2025DrugsFDA
Direct Rx recalls Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
August 13, 2025DrugsFDA
Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Ph
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
April 23, 2025DrugsFDA
Direct Rx recalls CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC
Hazard: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
November 13, 2024DrugsFDA
Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT
Hazard: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
April 12, 2023DrugsFDA
Direct Rx recalls Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72
Hazard: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
April 12, 2023DrugsFDA
Direct Rx recalls Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx
Hazard: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
April 12, 2023DrugsFDA
Direct Rx recalls Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC
Hazard: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC619
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: D
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: D
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By:
Hazard: cGMP deviations
April 5, 2023DrugsFDA
Direct Rx recalls Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count
Hazard: cGMP deviations
January 18, 2023DrugsFDA
Direct Rx recalls Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, D
Hazard: cGMP deviation: discontinue of stability support for product.
September 21, 2022DrugsFDA
Direct Rx recalls Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534,
Hazard: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
June 8, 2022DrugsFDA
Direct Rx recalls Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceutica
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 1, 2022DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. F
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
June 1, 2022DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
June 1, 2022DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
June 1, 2022DrugsFDA
Direct Rx recalls Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Hazard: CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
March 30, 2022DrugsFDA
Direct Rx recalls Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 M
Hazard: Defective Container: Leaking containers.
March 16, 2022DrugsFDA
Direct Rx recalls Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Dist
Hazard: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
March 16, 2022DrugsFDA
Direct Rx recalls Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distr
Hazard: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
March 9, 2022DrugsFDA
Direct Rx recalls Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By A
Hazard: Failed impurities/degradation specifications