Dawsonville, GA, United States
Direct Rx recalls
20 recalls recorded since 2018, most recently on 22 June 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls20
Ongoing (FDA)5
Terminated or completed15
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 22 June 2026
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0617-2026
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Ongoing Class II Drugs
- Recall started
- 7 March 2025
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0567-2025, D-0568-2025
- Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
- Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Br
Ongoing Class II Drugs
- Recall started
- 31 January 2025
- Reason
- 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
- Distribution
- Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0364-2025
- CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Ongoing Class II Drugs
- Recall started
- 9 August 2024
- Reason
- Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0041-2025
- Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61
Ongoing Class II Drugs
- Recall started
- 22 March 2023
- Reason
- CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0508-2023, D-0509-2023, D-0507-2023
- 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 only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
- Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
- Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Terminated Class II Drugs
- Recall started
- 13 March 2023
- Terminated
- 17 June 2024
- Reason
- cGMP deviations
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0480-2023, D-0483-2023, D-0486-2023, D-0478-2023, D-0482-2023, D-0481-2023, D-0479-2023, D-0484-2023, D-0477-2023, D-0476-2023, D-0485-2023
- Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- and 3 more product lines
Terminated Class II Drugs
- Recall started
- 2 November 2022
- Terminated
- 30 September 2024
- Reason
- cGMP deviation: discontinue of stability support for product.
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0101-2023
- Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Completed Class II Drugs
- Recall started
- 12 September 2022
- Reason
- CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- Distribution
- Physicians and Medical Facilities in GA and ID
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1535-2022
- Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Terminated Class II Drugs
- Recall started
- 13 May 2022
- Terminated
- 30 September 2024
- Reason
- CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Distribution
- Nationwide to the U.S. market
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0888-2022
- Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Terminated Class II Drugs
- Recall started
- 11 May 2022
- Terminated
- 2 December 2022
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0893-2022, D-0894-2022, D-0895-2022
- Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
- Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
- Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Terminated Class II Drugs
- Recall started
- 5 May 2022
- Terminated
- 5 October 2023
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- AL, GA, FL, LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0971-2022
- Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Terminated Class II Drugs
- Recall started
- 4 March 2022
- Terminated
- 2 December 2022
- Reason
- CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
- Distribution
- FL, GA, LA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0650-2022, D-0651-2022
- Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
- Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
Terminated Class II Drugs
- Recall started
- 17 February 2022
- Terminated
- 4 October 2023
- Reason
- Failed impurities/degradation specifications
- Distribution
- Florida
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0637-2022
- Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Terminated Class II Drugs
- Recall started
- 7 December 2021
- Terminated
- 5 October 2023
- Reason
- Defective Container: Leaking containers.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0714-2022
- Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Terminated Class II Drugs
- Recall started
- 14 September 2021
- Terminated
- 22 October 2021
- Reason
- CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Distribution
- FL only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0829-2021
- Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
Terminated Class II Drugs
- Recall started
- 2 March 2021
- Terminated
- 21 September 2021
- Reason
- cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
- Distribution
- GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0300-2021
- Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Terminated Class II Drugs
- Recall started
- 12 October 2020
- Terminated
- 22 September 2021
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0058-2021
- Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Terminated Class II Drugs
- Recall started
- 15 January 2020
- Terminated
- 7 December 2020
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Distribution
- FL, GA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0017-2021, D-0016-2021
- Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
- Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Terminated Class II Drugs
- Recall started
- 30 April 2019
- Terminated
- 4 December 2020
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
- Distribution
- GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0018-2021
- Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Terminated Class II Drugs
- Recall started
- 12 March 2019
- Terminated
- 21 September 2021
- Reason
- CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0032-2021
- Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.