# FDA recall D-1288-2019

> **Heritage Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-05-03.

## Product

Losartan Potassium Tablets USP 100 mg 90 film coated tablets   Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108  SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India.   Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784)    NDC 23155-646-09

## 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 at the manufacturer

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1288-2019
- **Recalling firm:** Heritage Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-03
- **Report date:** 2019-05-29
- **Termination date:** 2020-11-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1288-2019

## Citation

> AI Analytics. FDA recall D-1288-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1288-2019. Source: US FDA. Licensed CC0.

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