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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