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

Losartan Potassium Tablets, USP, 100 mg recalled

Legacy Pharmaceutical Packaging is recalling Losartan Potassium Tablets, USP, 100 mg, distributed in Arkansas, California, Georgia, Indiana, Maryland. The recall was initiated on 1 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes180886, Nov-19; 180887, 180888, 180905, Dec-19; 181123, Sep-2019; 181124, Oct-2019, 181125, Aug-19, 181351, Nov-19, 181352, Dec-19, 181551, Nov-19, 181628, 181629, 181727, 181728, Jun-20; 181890, Mar-20; 181891, 181897, Jun-20; 182114, Mar-20; 182119, 182120, Jun-20

Quantity recalled2,497,856 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-1050-2019
FDA event ID: 82326
Recalling firm: Legacy Pharmaceutical Packaging, Earth City, MO
Classification: Class II
Status: Ongoing
Recall initiated: 1 Mar 2019
FDA classified: 21 Mar 2019
Reported: 27 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

1 Mar 2019	Recall initiated by company
21 Mar 2019	Classified by FDA	+20 days
27 Mar 2019	Published in enforcement report	+6 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: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

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, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54

Where it was distributed

Wal-Mart distribution centers in AR, CA, GA, IN and MD

Arkansas California Georgia Indiana Maryland

Stores named: Walmart

Questions about this recall

Is Losartan Potassium Tablets, USP, 100 mg recalled?

Yes. Legacy Pharmaceutical Packaging recalled Losartan Potassium Tablets, USP, 100 mg on 1 Mar 2019. The recall is Class II and its status is Ongoing. Recall number D-1050-2019.

Why was it recalled?

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Which lots are affected?

180886, Nov-19; 180887, 180888, 180905, Dec-19; 181123, Sep-2019; 181124, Oct-2019, 181125, Aug-19, 181351, Nov-19, 181352, Dec-19, 181551, Nov-19, 181628, 181629, 181727, 181728, Jun-20; 181890, Mar-20; 181891, 181897, Jun-20; 182114, Mar-20; 182119, 182120, Jun-20

Where was it sold?

Wal-Mart distribution centers in AR, CA, GA, IN and MD

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 Legacy Pharmaceutical Packaging

All 12

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024Drug	CLASS II	Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride	Legacy Pharmaceutical Packaging	Manufacturing (CGMP) Deviations	AR, CA
7 Oct 2020Drug	CLASS III	Metformin Hydrochloride Tablets USP, 1000 mg recalled	Legacy Pharmaceutical Packaging	Packaging Defects	AR, GA
8 May 2019Drug	CLASS II	Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical	Legacy Pharmaceutical Packaging	Nitrosamine Impurity	AZ, TN
10 Apr 2019Drug	CLASS II	Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical	Legacy Pharmaceutical Packaging	Nitrosamine Impurity	AZ, IN, TN
27 Mar 2019Drug	CLASS II	Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical	Legacy Pharmaceutical Packaging	Nitrosamine Impurity	5 states

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