CLASS II ONGOING Drug recall · Reported 8 May 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 18 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCount, lots, expiry: [90-count bottle] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021

Quantity recalled65,184 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-1266-2019
FDA event ID: 82661
Recalling firm: Torrent Pharma, Basking Ridge, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 18 Apr 2019
FDA classified: 1 May 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

18 Apr 2019	Recall initiated by company
1 May 2019	Classified by FDA	+13 days
8 May 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

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 18 Apr 2019. The recall is Class II and its status is Ongoing. Recall number D-1266-2019.

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] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021

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.

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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