Drug recall: DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127…

Class II FDA enforcement event 95922. Recall start date: 4 Dec 2024. Status in the FDA record: Terminated. Termination date: 21 Mar 2025.

Reason for recall, in the words of FDA

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

PD-Rx Pharmaceuticals, Inc. started this drug recall on 4 Dec 2024. The firm address in the FDA record is in Oklahoma City, OK. FDA put the recall in Class II. FDA event 95922 has 1 product record. The first FDA enforcement report date is 1 Jan 2025. The record gives the status Terminated, with the termination date 21 Mar 2025.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distributed within US: FL, MS, WI

Recalling firm

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

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 95922: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0163-2025	DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90	70, 90-count bottles	Class II	Terminated	1 Jan 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2024: 319
Share of these events in Class II: 71%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 17

Other events of the firm

Other FDA enforcement events of PD-Rx Pharmaceuticals, Inc.
Initiated	Product (first record)	Type	Class	Records
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
7 Aug 2018	Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-	Drug	Class II	1

PD-Rx Pharmaceuticals, Inc.: all 17 events

Official channels

FDA enforcement report D-0163-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 95922. https://recallregister.com/fda/ii/95922/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed within US: FL, MS, WI
What quantity of product is in FDA event 95922?: The FDA record gives this quantity: 70, 90-count bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2024 have the same class?: 71% of the 319 drug events that started in 2024 are in Class II.