# FDA recall D-1250-2019

> **AVKARE Inc.** · Class II · drug recall initiated 2019-04-24.

## Product

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

## 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 of 0.96 parts per million.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1250-2019
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-04-24
- **Report date:** 2019-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1250-2019

## Citation

> AI Analytics. FDA recall D-1250-2019. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-1250-2019. Source: US FDA. Licensed CC0.

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