CLASS II ONGOING Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report

Losartan Potassium Tablets, USP, 100 mg, a) recalled by Torrent Pharma

Torrent Pharma is recalling Losartan Potassium Tablets, USP, 100 mg, a) (, distributed nationwide in the US. The recall was initiated on 28 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCount, lots, expiry: [90-count bottle] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021

Quantity recalled121,668 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-1116-2019
FDA event ID: 82585
Recalling firm: Torrent Pharma, Basking Ridge, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2019
FDA classified: 10 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

28 Feb 2019	Recall initiated by company
10 Apr 2019	Classified by FDA	+41 days
17 Apr 2019	Published in enforcement report	+7 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 of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

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 TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Where it was distributed

Nationwide USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Losartan Potassium Tablets, USP, 100 mg, a) ( recalled?

Yes. Torrent Pharma recalled Losartan Potassium Tablets, USP, 100 mg, a) ( on 28 Feb 2019. The recall is Class II and its status is Ongoing. Recall number D-1116-2019.

Why was it recalled?

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Which lots are affected?

Count, lots, expiry: [90-count bottle] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021

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 21 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 Torrent Pharma

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11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
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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 64

Reported	Class	Recall	Company	Reason	Where
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 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
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 50 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
8 Jun 2022Drug	CLASS II	Losartan Potassium Tablets, USP 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Potency & Assay	Nationwide