CLASS II Drug recall · Reported 6 Jul 2022 · FDA Enforcement Report

Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx Pharmaceuticals

PD-Rx Pharmaceuticals is recalling Losartan Potassium Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 6 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22

NDC72789-163, 72789-164, 72789-165

UPC0372789163901, 0372789164908, 0372789165905, 372789163901

Quantity recalled1441 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1161-2022
FDA event ID: 90383
Recalling firm: PD-Rx Pharmaceuticals, Oklahoma City, OK
Brand: Losartan Potassium
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2022
FDA classified: 27 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

6 Jun 2022	Recall initiated by company
27 Jun 2022	Classified by FDA	+21 days
6 Jul 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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 was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 90383

This product is part of a recall event; the main page for the event is Losartan Potassium Tablets, USP 50 mg recalled by PD-Rx Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
6 Jul 2022	CLASS II	Losartan Potassium Tablets, USP 50 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022	CLASS II	Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide

More recalls from PD-Rx Pharmaceuticals

All 25

Reported	Class	Recall	Company	Reason	Where
1 Jan 2025Drug	CLASS II	DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Nitrosamine Impurity	FL, MS, WI
10 May 2023Drug	CLASS II	Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Other Losartan recalls

All 97

Reported	Class	Recall	Company	Reason	Where
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
12 Jul 2023Drug	CLASS II	Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Foreign Material	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 50 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide