# FDA recall D-1040-2019

> **Macleods Pharma Usa Inc** · Class II · drug recall initiated 2019-02-21.

## Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for:  Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by:  Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India.  NDC 33342-0052-10

## Reason for recall

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

## Distribution

NJ, NY, FL

## Key facts

- **Recall number:** D-1040-2019
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-21
- **Report date:** 2019-03-27
- **Termination date:** 2020-09-28

- **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-1040-2019

## Citation

> AI Analytics. FDA recall D-1040-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1040-2019. Source: US FDA. Licensed CC0.

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