Direct Rx

Complete recall history across all FDA and CPSC categories — 36 total recalls

Direct Rx appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (36)

FDA drug safety enforcement actions by Direct Rx

Date Product Reason Class
Mar 7, 2025 Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity abov... Class II
Mar 7, 2025 Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distribu... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity abov... Class II
Jan 31, 2025 CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, ... Defective Container: Unable to get the solution out of the bottle as the spik... Class II
Aug 9, 2024 Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 80... Failed Impurities/Degradation Specifications: Product failed impurity specifi... Class II
Mar 22, 2023 Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distribute... CGMP Deviations: Repackaging firm recalling due to potential product cross co... Class II
Mar 22, 2023 Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed ... CGMP Deviations: Repackaging firm recalling due to potential product cross co... Class II
Mar 22, 2023 Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b... CGMP Deviations: Repackaging firm recalling due to potential product cross co... Class II
Mar 13, 2023 Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II
Mar 13, 2023 Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-c... cGMP deviations Class II
Mar 13, 2023 Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... cGMP deviations Class II
Mar 13, 2023 Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II
Mar 13, 2023 Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72... cGMP deviations Class II
Mar 13, 2023 Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II
Mar 13, 2023 Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II
Mar 13, 2023 Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC... cGMP deviations Class II
Mar 13, 2023 Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-04... cGMP deviations Class II
Mar 13, 2023 Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... cGMP deviations Class II
Mar 13, 2023 Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II
Nov 2, 2022 Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... cGMP deviation: discontinue of stability support for product. Class II
Sep 12, 2022 Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distrib... CGMP Deviations: Product complaints reporting the product to have a gritty te... Class II
May 13, 2022 Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Dist... CGMP Deviations: Gaps in the quality system in the Quality Control microbiolo... Class II
May 11, 2022 Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II
May 11, 2022 Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distribute... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II
May 11, 2022 Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distribut... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II
May 5, 2022 Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonv... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Mar 4, 2022 Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... CGMP Deviations: The Recall is due to the potential cross-contamination at th... Class II
Mar 4, 2022 Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... CGMP Deviations: The Recall is due to the potential cross-contamination at th... Class II
Feb 17, 2022 Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... Failed impurities/degradation specifications Class II
Dec 7, 2021 Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distri... Defective Container: Leaking containers. Class II
Sep 14, 2021 Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Di... CGMP deviations: Gaps in the quality system in the Quality Control microbiolo... Class II
Mar 2, 2021 Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Pac... cGMP deviations: The quantity of active ingredient used for the product lot w... Class II
Oct 12, 2020 Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Daw... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... Class II
Jan 15, 2020 Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-3... CGMP Deviations: Presence of NDMA impurity detected in product. Class II
Jan 15, 2020 Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dir... CGMP Deviations: Presence of NDMA impurity detected in product. Class II
Apr 30, 2019 Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distribute... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... Class II
Mar 12, 2019 Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx D... CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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