CLASS II Drug recall · Reported 11 May 2022 · FDA Enforcement Report

Losartan Potassium Tablets, USP, 100 mg, a) bottles recalled

Macleods Pharma Usa is recalling Losartan Potassium Tablets, USP, 100 mg, a) bottles (, distributed nationwide in the US. The recall was initiated on 15 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023

NDC33342-044, 33342-045, 33342-046

Quantity recalled3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets

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-0834-2022
FDA event ID: 90037
Recalling firm: Macleods Pharma Usa, Plainsboro, NJ
Brand: Losartan Potassium
Manufacturer: Macleods Pharmaceuticals Limited
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2022
FDA classified: 3 May 2022
Reported: 11 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

15 Apr 2022	Recall initiated by company
3 May 2022	Classified by FDA	+18 days
11 May 2022	Published in enforcement report	+8 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, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Where it was distributed

Product was distributed nationwide.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023

Where was it sold?

Product was distributed 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

5 other products · FDA event 90037

This product is part of a recall event; the main page for the event is Losartan Potassium Tablets, USP, 50 mg, a) bottles recalled.

Reported	Class	Recall	Company	Reason	Where
11 May 2022	CLASS II	Losartan Potassium Tablets, USP, 50 mg, a) bottles recalledLosartan Potassium	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022	CLASS II	Losartan Potassium Tablets, USP, 25 mg, a) bottles recalledLosartan Potassium	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide

More recalls from Macleods Pharma Usa

All 34

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Drug	CLASS II	Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium	Macleods Pharma USA	Potency & Assay	Nationwide
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma USA	Packaging Defects	Nationwide
13 Jul 2022Drug	CLASS II	Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone	Macleods Pharma Usa	Packaging Defects	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	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