# FDA recall D-0613-2020

> **Amneal Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-11-22.

## Product

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

## Reason for recall

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

## Distribution

Product was distributed throughout the United States.

## Key facts

- **Recall number:** D-0613-2020
- **Recalling firm:** Amneal Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-11-22
- **Report date:** 2019-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brookhaven, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2020

## Citation

> AI Analytics. FDA recall D-0613-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0613-2020. Source: US FDA. Licensed CC0.

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