# FDA recall D-0504-2019

> **Torrent Pharma Inc.** · Class II · drug recall initiated 2018-12-20.

## Product

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP,  100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

## Reason for recall

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0504-2019
- **Recalling firm:** Torrent Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-12-20
- **Report date:** 2019-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kalamazoo, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0504-2019

## Citation

> AI Analytics. FDA recall D-0504-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0504-2019. Source: US FDA. Licensed CC0.

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