# FDA recall D-0641-2020

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2019-12-17.

## Product

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India   Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ   NDC 68462-249-30

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Natiowide

## Key facts

- **Recall number:** D-0641-2020
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-12-17
- **Report date:** 2020-01-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2020

## Citation

> AI Analytics. FDA recall D-0641-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0641-2020. Source: US FDA. Licensed CC0.

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