# FDA recall D-0632-2020

> **Granules India Limited** · Class II · drug recall initiated 2019-12-13.

## Product

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA  NDC 62207-773-32

## Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

## Distribution

OR, NY, NJ

## Key facts

- **Recall number:** D-0632-2020
- **Recalling firm:** Granules India Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-12-13
- **Report date:** 2020-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Qutbullapur Mandal, Ranga Redd, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0632-2020

## Citation

> AI Analytics. FDA recall D-0632-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0632-2020. Source: US FDA. Licensed CC0.

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