# FDA recall D-838-2013

> **Zydus Pharmaceuticals USA Inc** · Class I · drug recall initiated 2013-05-13.

## Product

Warfarin Sodium Tablets, USP 2 mg,  Rx Only, 1000 Tablets per bottle,  Manufactured by: Cadila Healthcare Ltd Ahmedabad, India,  Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ  08534, NDC 68382-053-10

## Reason for recall

Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-838-2013
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-13
- **Report date:** 2013-08-14
- **Termination date:** 2015-05-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-838-2013

## Citation

> AI Analytics. FDA recall D-838-2013. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-838-2013. Source: US FDA. Licensed CC0.

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