PD-Rx Pharmaceuticals, Inc.

• Metformin hydrochlorideGlumetza · 18 products
• CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 16 products
• MetoprololToprol XL, Lopressor, Kapspargo · 15 products
• Prednisone14 products
• Hydroxyzine14 products
• MethocarbamolRobaxin, Atmeksi, Tanlor · 14 products
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 13 products
• Penicillin v potassium13 products
• Phentermine hydrochlorideLomaira · 13 products
• LisinoprilZestril, Qbrelis · 13 products
• Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 12 products
• IbuprofenIbu, Caldolor · 11 products
• Minocycline hydrochlorideArestin, Zilxi, Amzeeq · 11 products
• AmoxicillinAmoxil · 10 products
• Glimepiride10 products
• Losartan potassiumLosortan Potassium, Cozaar, Arbli · 10 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 9 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 9 products
• GlipizideGlucotrol XL · 8 products
• FamotidinePepcid · 8 products
• TopiramateTopamax, Qudexy XR, Trokendi XR · 8 products
• SildenafilViagra, Vybrique, Revatio · 8 products
• LorazepamAtivan, Loreev XR · 8 products
• CarvedilolCoreg, Coreg CR · 8 products
• MeloxicamZybic, Xifyrm, Qamzova · 8 products
• Dicyclomine hydrochloride8 products
• Sertraline hydrochlorideZoloft · 8 products
• GabapentinNeurontin, Gralise, Relgaabi · 8 products
• Cephalexin8 products
• TizanidineZanaflex, Ontralfy · 8 products
• BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 8 products
• BuspironeBucapsol · 7 products
• FurosemideLasix, Furoscix, Lasix Onyu · 7 products
• TadalafilCialis, Tadliq, Adcirca · 7 products
• OxybutyninOxytrol · 7 products
• NaproxenNaprelan, Rugby All Day Relief · 7 products
• FluoxetineProzac · 7 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 7 products
• Promethazine hydrochloridePhenergan, Promethegan · 7 products
• NifedipineProcardia XL · 6 products

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Showing the 125 newest of 444 applications. Full lists: Drugs@FDA →

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2022

1. June 6, 2022 · Class II · Terminated · D-1161-2022 · Losartan potassium

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102,

2. June 6, 2022 · Class II · Terminated · D-1162-2022 · Losartan potassium

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102,

3. June 6, 2022 · Class II · Terminated · D-1163-2022 · Losartan potassium

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102

2020

1. October 6, 2020 · Class II · Terminated · D-0060-2021 · Metformin hydrochloride

   CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

   metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60

2. October 6, 2020 · Class II · Terminated · D-0059-2021 · Metformin hydrochloride

   CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

   metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Ok

3. June 5, 2020 · Class II · Terminated · D-1333-2020 · Metformin hydrochloride

   CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

   metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx

4. May 15, 2020 · Class II · Terminated · D-1276-2020 · Doxycycline

   Failed dissolution specifications

   Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28),

2019

1. March 8, 2019 · Class II · Terminated · D-0341-2021 · Losartan potassium

   CGMP deviation: Product found to contain trace amounts of NMBA

   Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90

2018

1. August 7, 2018 · Class II · Terminated · D-1127-2018 · Doxycycline

   Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

   Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bot

2017

1. August 11, 2017 · Class III · Terminated · D-1118-2017 · Phentermine hydrochloride

   Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

   Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-6

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1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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