# FDA recall D-1466-2019

> **MAJOR PHARMACEUTICALS** · Class II · drug recall initiated 2019-01-10.

## Product

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.

## 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

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1466-2019
- **Recalling firm:** MAJOR PHARMACEUTICALS
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-10
- **Report date:** 2019-07-17
- **Termination date:** 2023-02-19

- **Voluntary/Mandated:** —
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1466-2019

## Citation

> AI Analytics. FDA recall D-1466-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1466-2019. Source: US FDA. Licensed CC0.

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