# FDA recall D-0732-2016

> **Teva North America** · Class II · drug recall initiated 2015-12-21.

## Product

Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89

## Reason for recall

Failed Dissolution Specifications: low test results at the 18 month time-point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0732-2016
- **Recalling firm:** Teva North America
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-21
- **Report date:** 2016-03-09
- **Termination date:** 2017-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0732-2016

## Citation

> AI Analytics. FDA recall D-0732-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0732-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*