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.

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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