# FDA recall D-1119-2019

> **Torrent Pharma Inc.** · Class II · drug recall initiated 2019-02-28.

## Product

Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg,  a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India.  For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

## 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.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1119-2019
- **Recalling firm:** Torrent Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-02-28
- **Report date:** 2019-04-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1119-2019

## Citation

> AI Analytics. FDA recall D-1119-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1119-2019. Source: US FDA. Licensed CC0.

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