Drug recall: Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major…

Class II FDA enforcement event 83208. Recall start date: 10 Jan 2019. Status in the FDA record: Terminated. Termination date: 19 Feb 2023.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

MAJOR PHARMACEUTICALS started this drug recall on 10 Jan 2019. The firm address in the FDA record is in Livonia, MI. FDA put the recall in Class II. FDA event 83208 has 1 product record. The first FDA enforcement report date is 17 Jul 2019. The record gives the status Terminated, with the termination date 19 Feb 2023.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide.

Recalling firm

MAJOR PHARMACEUTICALS, Livonia, MI.

Recalling firm: The firm that the FDA record names for a recall.

Products

1 product record in the event.

FDA event 83208: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1466-2019	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.	3,102 Cartons (310,200 tablets)	Class II	Terminated	17 Jul 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2019: 362
Share of these events in Class II: 68%
Product records in this event: 1Median of the firm: 2
Events of the firm on the register: 6

Other events of the firm

Other FDA enforcement events of MAJOR PHARMACEUTICALS
Initiated	Product (first record)	Type	Class	Records
13 Jul 2026	Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Pack	Drug	Class II	12
24 Apr 2019	DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr	Drug	Class II	1
30 Jul 2018	Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceutic	Drug	Class II	1
18 Jul 2018	Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-65	Drug	Class II	2
26 Jun 2018	Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt	Drug	Class III	2

MAJOR PHARMACEUTICALS: all 6 events

Official channels

FDA enforcement report D-1466-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 83208. https://recallregister.com/fda/ii/83208/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide.
What quantity of product is in FDA event 83208?: The FDA record gives this quantity: 3,102 Cartons (310,200 tablets)
How many drug recalls of 2019 have the same class?: 68% of the 362 drug events that started in 2019 are in Class II.
How many FDA recalls does MAJOR PHARMACEUTICALS have?: MAJOR PHARMACEUTICALS is the recalling firm in 6 enforcement events on this register. This event is 1 of them.