Food, drugs, devices › PD-Rx Pharmaceuticals, Inc.

Drug recall: Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14

FDA enforcement event 72941 · Class III · initiated 21 Jul 2015 · status Terminated · terminated 23 Dec 2016

DrugVoluntary: Firm initiated1 product recordOklahoma City, OK

PD-Rx Pharmaceuticals, Inc. (Oklahoma City, OK) initiated this drug recall on 21 Jul 2015; FDA lists 1 product record under event 72941, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 31% of the 292 drug enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 23 Dec 2016. Initiation: voluntary: firm initiated. PD-Rx Pharmaceuticals, Inc. has 17 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK.

Reason for recall

"Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0574-2016	Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC…	1685 bottles	Class III	Terminated	27 Jan 2016

Context

31%of 2015 drug events are Class III292 events that year

1product record in this eventfirm median: 1

17events on this register for the firm

Other enforcement events for PD-Rx Pharmaceuticals, Inc.

Initiated	Product (first record)	Type	Class	Records
4 Dec 2024	DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC	Drug	Class II	1
6 Apr 2023	Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pha	Drug	Class II	5
6 Jun 2022	Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.	Drug	Class II	3
6 Oct 2020	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-	Drug	Class II	2
17 Sep 2020	Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4)	Drug	Class II	1
5 Jun 2020	metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-00	Drug	Class II	1
5 Jun 2020	metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 4	Drug	Class II	1
15 May 2020	Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-1	Drug	Class II	1
10 Jan 2020	ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-84	Drug	Class II	1
8 Mar 2019	Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets	Drug	Class II	1

All 17 events for PD-Rx Pharmaceuticals, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 23 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.