CLASS II Drug recall · Reported 17 Jul 2019 · FDA Enforcement Report

Losartan Potassium Tablets recalled by Major Pharmaceuticals

Major Pharmaceuticals is recalling Losartan Potassium Tablets, USP, distributed nationwide in the US. The recall was initiated on 10 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMajor Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.

Quantity recalled3,102 Cartons (310,200 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-1466-2019
FDA event ID: 83208
Recalling firm: Major Pharmaceuticals, Livonia, MI
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2019
FDA classified: 9 Jul 2019
Reported: 17 Jul 2019
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

10 Jan 2019	Recall initiated by company
9 Jul 2019	Classified by FDA	+180 days
17 Jul 2019	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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

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. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

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 at the manufacturer

Which lots are affected?

Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.

Where was it sold?

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.

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29 Jul 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg) recalledLevothyroxine Sodium	Major Pharmaceuticals	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 50 mcg recalledLevothyroxine Sodium	Major Pharmaceuticals	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg) recalledLevothyroxine Sodium	Major Pharmaceuticals	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg) recalledLevothyroxine Sodium	Major Pharmaceuticals	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 25 mcg recalledLevothyroxine Sodium	Major Pharmaceuticals	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