# FDA recall D-0833-2022

> **Macleods Pharma Usa Inc** · Class II · drug recall initiated 2022-04-15.

## Product

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

## Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0833-2022
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-15
- **Report date:** 2022-05-11
- **Termination date:** 2023-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0833-2022

## Citation

> AI Analytics. FDA recall D-0833-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0833-2022. Source: US FDA. Licensed CC0.

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