CLASS II ONGOING Drug recall · Reported 15 Apr 2020 · FDA Enforcement Report

Losartan Potassium Tablets, USP 50 mg, Bulk recalled

Teva Pharmaceuticals USA is recalling Losartan Potassium Tablets, USP 50 mg, Bulk, distributed in California. The recall was initiated on 25 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 1195625A, 1195624A, 1195623A, exp. date 03/2020

Quantity recalledN/A

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-1101-2020
FDA event ID: 85306
Recalling firm: Teva Pharmaceuticals USA, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 25 Mar 2020
FDA classified: 7 Apr 2020
Reported: 15 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

25 Mar 2020	Recall initiated by company
7 Apr 2020	Classified by FDA	+13 days
15 Apr 2020	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: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

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 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00

Where it was distributed

Bulk product was distributed to one re-packager in California.

California

Questions about this recall

Why was it recalled?

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Which lots are affected?

Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020

Where was it sold?

Bulk product was distributed to one re-packager in California.

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

2 other products · FDA event 85306

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020	CLASS II	Losartan Potassium Tablets, USP 100 mg, Bulk recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	CA
15 Apr 2020	CLASS II	Losartan Potassium Tablets, USP 25 mg, Bulk recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	CA

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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