--- title: "Direct Rx Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Direct Rx recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/direct-rx/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Direct Rx recall records **8** reported ongoing 30 records in this archive. Latest source date Jun 22, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 22, 2026 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-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-a/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Reported ongoing Distribution: U.S. Nationwide [Official source for DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBA...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0617-2026%22) Mar 7, 2025 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0567-2025-duloxetine-d-r-20-mg-30-caps-30-count-bottle-rx-only-packaged-distributed-by-direct-rx-dist-by-breck/) CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class II Reported ongoing Distribution: Nationwide [Official source for Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, D...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0567-2025%22) Mar 7, 2025 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-0568-2025-duloxetine-d-r-30-mg-30-caps-rx-only-packaged-as-a-30-count-bottle-ndc-61919-0482-30-b-60-count-bott/) CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class II Reported ongoing Distribution: Nationwide [Official source for Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0568-2025%22) Jan 31, 2025 FDA drug enforcement ### [CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.](https://isitonrecall.com/recall/fda-drug-d-0364-2025-ciprofloxacin-ophth-solution-0-3-5ml-bottle-rx-only-generic-for-ciloxan-packaged-and-distributed-by/) 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 Class II Reported ongoing Distribution: Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID [Official source for CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distrib...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0364-2025%22) Aug 9, 2024 FDA drug enforcement ### [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 Laboratorie...](https://isitonrecall.com/recall/fda-drug-d-0041-2025-ibuprofen-800mg-generic-for-motrin-each-tablet-contains-ibuprofen-usp-800-mg-packaged-and-distribute/) Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and D...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0041-2025%22) Mar 22, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0507-2023-alprazolam-c-iv-0-5-mg-30-tabs-per-bottle-rx-only-packaged-and-distributed-by-direct-rx-dawsonville/) CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Daws...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0507-2023%22) Mar 22, 2023 FDA drug enforcement ### [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,...](https://isitonrecall.com/recall/fda-drug-d-0508-2023-alprazolam-c-iv-1-mg-packaged-in-a-30-tabs-per-bottle-ndc-72189-213-30-b-60-tabs-per-bottle-ndc-7218/) CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0508-2023%22) Mar 22, 2023 FDA drug enforcement ### [Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.](https://isitonrecall.com/recall/fda-drug-d-0509-2023-alprazolam-c-iv-2-mg-60-tabs-per-bottle-rx-only-packaged-and-distributed-by-direct-rx-dawsonville-ga/) CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawson...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0509-2023%22) Mar 13, 2023 FDA drug enforcement ### [Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: ...](https://isitonrecall.com/recall/fda-drug-d-0476-2023-montelukast-sodium-tablets-usp-10-mg-tablets-rx-only-packaged-as-a-30-count-bottle-ndc-61919-0009-30/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 619...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0476-2023%22) Mar 13, 2023 FDA drug enforcement ### [Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx](https://isitonrecall.com/recall/fda-drug-d-0477-2023-finasteride-usp-5-mg-tablets-rx-only-packaged-as-a-90-count-bottle-ndc-61919-0733-90-packaged-and-di/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packag...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0477-2023%22) Mar 13, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0478-2023-ropinirole-usp-0-25-mg-tablets-rx-only-packaged-as-a-30-count-bottle-ndc-72189-0364-30-packaged-and/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Pack...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0478-2023%22) Mar 13, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0479-2023-ropinirole-usp-1-mg-tablets-rx-only-packaged-as-a-30-count-bottle-ndc-72189-0364-30-packaged-and-dis/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Package...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0479-2023%22) Mar 13, 2023 FDA drug enforcement ### [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, Dawso...](https://isitonrecall.com/recall/fda-drug-d-0480-2023-glimepiride-usp-1-mg-tablets-rx-only-packaged-as-a-a-30-count-bottle-ndc-61919-0723-30-b-90-count-bo/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0480-2023%22) Mar 13, 2023 FDA drug enforcement ### [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, Dawso...](https://isitonrecall.com/recall/fda-drug-d-0481-2023-glimepiride-usp-2-mg-tablets-rx-only-packaged-as-a-a-30-count-bottle-ndc-61919-0488-30-b-90-count-bo/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0481-2023%22) Mar 13, 2023 FDA drug enforcement ### [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, Dawso...](https://isitonrecall.com/recall/fda-drug-d-0482-2023-glimepiride-usp-4-mg-tablets-rx-only-packaged-as-a-a-30-count-bottle-ndc-61919-0250-30-b-90-count-bo/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0482-2023%22) Mar 13, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0483-2023-simvastatin-usp-5-mg-tablets-rx-only-packaged-as-a-90-count-bottle-ndc-61919-0710-90-packaged-and-di/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Package...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0483-2023%22) Mar 13, 2023 FDA drug enforcement ### [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, Dawso...](https://isitonrecall.com/recall/fda-drug-d-0484-2023-simvastatin-usp-10-mg-tablets-rx-only-packaged-as-a-a-30-count-bottle-ndc-61919-0688-30-b-90-count-b/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0484-2023%22) Mar 13, 2023 FDA drug enforcement ### [Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Daws...](https://isitonrecall.com/recall/fda-drug-d-0485-2023-simvastatin-usp-20-mg-tablets-rx-only-packaged-as-a-a-30-count-bottle-ndc-61919-0446-30-b-90-count-b/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0485-2023%22) Mar 13, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0486-2023-simvastatin-usp-40-mg-rx-only-packaged-as-a-90-count-bottle-ndc-61919-0431-90-packaged-and-distribut/) cGMP deviations Class II Reported terminated Distribution: Nationwide in the USA [Official source for Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0486-2023%22) Nov 2, 2022 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0101-2023-moxifloxacin-ophthalmic-solution-0-5-3-ml-rx-only-packaged-and-distributed-by-direct-rx-llc-94-world/) cGMP deviation: discontinue of stability support for product. Class II Reported terminated Distribution: FL [Official source for Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LL...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0101-2023%22) ## Reasons in these listed records - CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - 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 - Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. These examples come from this result page and are not a ranking of every recall reason. ## Checking Direct Rx ### Is there a recall on direct rx right now? This archive contains 30 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Direct Rx](https://isitonrecall.com/check/?q=Direct%20Rx) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)