CLASS II Drug recall · Reported 5 May 2021 · FDA Enforcement Report

Losartan Potassium USP, 50 mg recalled by PD-Rx Pharmaceuticals

PD-Rx Pharmaceuticals is recalling Losartan Potassium USP, 50 mg, distributed in 14 states. The recall was initiated on 8 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: A19B99 Exp. 11/30/2019; B19A26 Exp. 11/30/2019; B19A69 Exp. 11/30/2019; E18F12 Exp.: 09/30/19; F18A12 Exp.: 09/30/19; F18F06 Exp.: 09/30/19; G18B43 Exp.: 09/30/19; G18C43 Exp.: 09/30/19; G18F75 Exp.: 09/30/19; H18D55 Exp.: 09/30/19; I18A11 Exp.: 09/30/19; I18E32 Exp.: 09/30/19; J18A90 Exp.: 09/30/19; J18D50 Exp. 11/30/2019; L18D01 Exp. 11/30/2019

NDC43063-854

UPC0343063854907

Quantity recalled576 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-0341-2021
FDA event ID: 87774
Recalling firm: PD-Rx Pharmaceuticals, Oklahoma City, OK
Brand: Losartan Potassium
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2019
FDA classified: 26 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

8 Mar 2019	Recall initiated by company
26 Apr 2021	Classified by FDA	+780 days
5 May 2021	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 deviation: Product found to contain trace amounts of NMBA

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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 was distributed

AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY

Alaska Arizona California Colorado Florida Kentucky Massachusetts Michigan Minnesota North Carolina Ohio Oregon Wisconsin Wyoming

Questions about this recall

Why was it recalled?

CGMP deviation: Product found to contain trace amounts of NMBA

Which lots are affected?

Lots: A19B99 Exp. 11/30/2019; B19A26 Exp. 11/30/2019; B19A69 Exp. 11/30/2019; E18F12 Exp.: 09/30/19; F18A12 Exp.: 09/30/19; F18F06 Exp.: 09/30/19; G18B43 Exp.: 09/30/19; G18C43 Exp.: 09/30/19; G18F75 Exp.: 09/30/19; H18D55 Exp.: 09/30/19; I18A11 Exp.: 09/30/19; I18E32 Exp.: 09/30/19; J18A90 Exp.: 09/30/19; J18D50 Exp. 11/30/2019; L18D01 Exp. 11/30/2019

Where was it sold?

AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY

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.

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 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	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