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PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.: 25 FDA recall reports
Every drug recall the FDA has published for PD-Rx Pharmaceuticals, Inc.. The fault, and how the agency graded it.
25Reports
0Class I
0Ongoing
2025-01-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK
D-0163-2025 · Class II · reported 2025-01-01 · Terminated
- Why it was recalled
- CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
- Product
- DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
- Where it went
- Distributed within US: FL, MS, WI
- How much
- 70, 90-count bottles
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorpora
D-0559-2023 · Class II · reported 2023-05-10 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
- Where it went
- Nationwide in the US.
- How much
- 186 bottles
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By:
D-0557-2023 · Class II · reported 2023-05-10 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
- Where it went
- Nationwide in the US.
- How much
- 352 bottles
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals In
D-0558-2023 · Class II · reported 2023-05-10 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
- Where it went
- Nationwide in the US.
- How much
- 37 bottles
Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Inc
D-0560-2023 · Class II · reported 2023-05-10 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
- Where it went
- Nationwide in the US.
- How much
- 520 bottles
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Inc
D-0561-2023 · Class II · reported 2023-05-10 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
- Where it went
- Nationwide in the US.
- How much
- 393 bottles
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuti
D-1162-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8
- Where it went
- Nationwide
- How much
- 687 bottles
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceu
D-1163-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5
- Where it went
- Nationwide
- How much
- 1320 bottles
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuti
D-1161-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1
- Where it went
- Nationwide
- How much
- 1441 bottles
Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a)
D-0341-2021 · Class II · reported 2021-05-05 · Terminated
- Why it was recalled
- CGMP deviation: Product found to contain trace amounts of NMBA
- Product
- 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
- Where it went
- AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
- How much
- 576 bottles
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 table
D-0060-2021 · Class II · reported 2020-11-11 · Terminated
- Why it was recalled
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Product
- 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
- Where it went
- AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- How much
- 125 bottles
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC:
D-0059-2021 · Class II · reported 2020-11-11 · Terminated
- Why it was recalled
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Product
- 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 Oklahoma City, OK 73127
- Where it went
- AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- How much
- 1683 bottles
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyro
D-0005-2021 · Class II · reported 2020-10-14 · Terminated
- Why it was recalled
- CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
- Product
- Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
- Where it went
- AZ, OK
- How much
- 20 bottles
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (ND
D-1333-2020 · Class II · reported 2020-07-01 · Terminated
- Why it was recalled
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Product
- 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 Pharmaceuticals Incorporated, Oklahoma City, OK 73127
- Where it went
- United States.
- How much
- 1969 bottles
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 table
D-1307-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Product
- metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
- Where it went
- United States
- How much
- 3703 bottles
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 5
D-1276-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- Failed dissolution specifications
- Product
- 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), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
- Where it went
- USA Nationwide
- How much
- 14,030 bottles
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (
D-0826-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
- Product
- ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
- Where it went
- AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
- How much
- N/A
Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles,
D-1127-2018 · Class II · reported 2018-09-05 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
- Product
- 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 bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.
- Where it went
- Nationwide in the USA.
- How much
- 6,641 bottles
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC
D-0341-2018 · Class II · reported 2018-02-07 · Terminated
- Why it was recalled
- CGMP deviations.
- Product
- PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
- Where it went
- Nationwide
- How much
- 7174 bottles
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c)
D-1118-2017 · Class III · reported 2017-08-30 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
- Product
- 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 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940
- Where it went
- Nationwide.
- How much
- 3440 bottles
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 7312
D-1057-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Failed Tablet/Capsule Specification: out of specification for tablet weight.
- Product
- Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
- Where it went
- Nationwide
- How much
- 100 bottles
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 5
D-0574-2016 · Class III · reported 2016-01-27 · Terminated
- Why it was recalled
- Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
- Product
- 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 Newtown, PA 18840.
- Where it went
- Nationwide
- How much
- 1685 bottles
Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX
D-0560-2016 · Class II · reported 2016-01-13 · Terminated
- Why it was recalled
- cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- Product
- Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
- Where it went
- Nationwide
- How much
- 45,022 bottles
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles,
D-0561-2016 · Class II · reported 2016-01-13 · Terminated
- Why it was recalled
- cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- Product
- Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
- Where it went
- Nationwide
- How much
- 17,533 bottles
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, I
D-0559-2016 · Class II · reported 2016-01-06 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
- Where it went
- Alabama
- How much
- 9 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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