PD-Rx Pharmaceuticals, Inc.
Complete recall history across all FDA and CPSC categories — 25 total recalls
PD-Rx Pharmaceuticals, Inc. 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 (25)
FDA drug safety enforcement actions by PD-Rx Pharmaceuticals, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 4, 2024 | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharma... | CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurit... | Class II |
| Apr 6, 2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... | CGMP deviations. | Class II |
| Apr 6, 2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... | CGMP deviations. | Class II |
| Apr 6, 2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India... | CGMP deviations. | Class II |
| Apr 6, 2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limite... | CGMP deviations. | Class II |
| Apr 6, 2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By... | CGMP deviations. | Class II |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed a... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Oct 6, 2020 | metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: ... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... | Class II |
| Oct 6, 2020 | metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Ok... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... | Class II |
| Sep 17, 2020 | Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), L... | CGMP deviations; repackaged product was recalled by the manufacturer because ... | Class II |
| Jun 5, 2020 | metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... | Class II |
| Jun 5, 2020 | metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... | Class II |
| May 15, 2020 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... | Failed dissolution specifications | Class II |
| Jan 10, 2020 | ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 430... | CGMP Deviations: Received notice from supplier of potential -Nitrosodimethyla... | Class II |
| Mar 8, 2019 | Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorpo... | CGMP deviation: Product found to contain trace amounts of NMBA | Class II |
| Aug 7, 2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 5... | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalle... | Class II |
| Jan 25, 2018 | PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC... | CGMP deviations. | Class II |
| Aug 11, 2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-cou... | Failed Impurities/Degradation Specifications:Out of specification results for... | Class III |
| Jul 28, 2017 | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals In... | Failed Tablet/Capsule Specification: out of specification for tablet weight. | Class II |
| Jul 21, 2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC ... | Failed impurities/Degradation specifications: out of specification results fo... | Class III |
| Jul 10, 2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Pac... | cGMP Deviations | Class II |
| Apr 29, 2015 | Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) ... | cGMP Deviations: This recall is a result of the original manufacturer's recal... | Class II |
| Apr 29, 2015 | Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 c... | cGMP Deviations: This recall is a result of the original manufacturer's recal... | 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.
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