CLASS II ONGOING Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report

Losartan Potassium and Hydrochlorothiazide Tablets recalled

Torrent Pharma is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 20 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCount, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019

Quantity recalled18,852 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-0504-2019
FDA event ID: 81838
Recalling firm: Torrent Pharma, Kalamazoo, MI
Classification: Class II
Status: Ongoing
Recall initiated: 20 Dec 2018
FDA classified: 15 Feb 2019
Reported: 27 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

20 Dec 2018	Recall initiated by company
15 Feb 2019	Classified by FDA	+57 days
27 Feb 2019	Published in enforcement report	+12 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: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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 and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

Where it was distributed

Nationwide USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019

Where was it sold?

Nationwide USA and Puerto Rico

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

4 other products · FDA event 81838

This product is part of a recall event; the main page for the event is Losartan Potassium Tablets, USP, 25 mg bottle recalled by Torrent Pharma.

Reported	Class	Recall	Company	Reason	Where
27 Feb 2019	CLASS II	Losartan Potassium Tablets, USP, 25 mg bottle recalled by Torrent Pharma	Torrent Pharma	Nitrosamine Impurity	Nationwide
27 Feb 2019	CLASS II	Losartan Potassium Tablets, USP, 100 mg, a) recalled by Torrent Pharma	Torrent Pharma	Nitrosamine Impurity	Nationwide
27 Feb 2019	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalled	Torrent Pharma	Nitrosamine Impurity	Nationwide
27 Feb 2019	CLASS II	Losartan Potassium Tablets, USP, 50 mg, a) bottle recalled	Torrent Pharma	Nitrosamine Impurity	Nationwide

More recalls from Torrent Pharma

All 84

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11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 May 2022Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium	Torrent Pharma	Manufacturing (CGMP) Deviations	Nationwide
19 Jan 2022Drug	CLASS II	Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine	Torrent Pharma	Potency & Assay	Nationwide
22 Dec 2021Drug	CLASS III	Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled	Torrent Pharma	Potency & Assay	Nationwide

Other Losartan recalls

All 98

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