← Every firm
Direct Rx FDA Recalls
32 recalls on file across drugs, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and DistrClass IIJun 22, 2026CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919Class IIMar 7, 2025CGMP Deviations: Presence of Nitrosamine Drug Substance Rela |
| Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge PhClass IIMar 7, 2025CGMP Deviations: Presence of Nitrosamine Drug Substance Rela |
| CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDCClass IIJan 31, 2025Defective Container: Unable to get the solution out of the b |
| Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Class IIAug 9, 2024Failed Impurities/Degradation Specifications: Product failed |
| 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 Class IIMar 22, 2023CGMP Deviations: Repackaging firm recalling due to potential |
| Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72Class IIMar 22, 2023CGMP Deviations: Repackaging firm recalling due to potential |
| Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC Class IIMar 22, 2023CGMP Deviations: Repackaging firm recalling due to potential |
| Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC619Class IIMar 13, 2023cGMP deviations |
| Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61Class IIMar 13, 2023cGMP deviations |
| Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed ByClass IIMar 13, 2023cGMP deviations |
| Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: DClass IIMar 13, 2023cGMP deviations |
| Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61Class IIMar 13, 2023cGMP deviations |
| Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61Class IIMar 13, 2023cGMP deviations |
| Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: DClass IIMar 13, 2023cGMP deviations |
| Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Class IIMar 13, 2023cGMP deviations |
| Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-countClass IIMar 13, 2023cGMP deviations |
| Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Class IIMar 13, 2023cGMP deviations |
| Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61Class IIMar 13, 2023cGMP deviations |
| Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, DClass IINov 2, 2022cGMP deviation: discontinue of stability support for product |
| Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Class IISep 12, 2022CGMP Deviations: Product complaints reporting the product to |
| Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534Class IIMay 13, 2022CGMP Deviations: Gaps in the quality system in the Quality C |
| Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.Class IIMay 11, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. FClass IIMay 11, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. Class IIMay 11, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin PharmaceuticaClass IIMay 5, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and DistrClass IIMar 4, 2022CGMP Deviations: The Recall is due to the potential cross-co |
| Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and DistClass IIMar 4, 2022CGMP Deviations: The Recall is due to the potential cross-co |
| Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By AClass IIFeb 17, 2022Failed impurities/degradation specifications |
| Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 MClass IIDec 7, 2021Defective Container: Leaking containers. |
| Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For GlenClass IISep 14, 2021CGMP deviations: Gaps in the quality system in the Quality C |
| Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx DawsonvClass IIMar 2, 2021cGMP deviations: The quantity of active ingredient used for |