# FDA recall D-0288-2015

> **Sandoz, Inc** · Class III · drug recall initiated 2014-10-02.

## Product

candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only,  Manufactured for Sandoz Inc., Princeton,  NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India,   NDC 0781-5938-92

## Reason for recall

Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0288-2015
- **Recalling firm:** Sandoz, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-02
- **Report date:** 2014-12-10
- **Termination date:** 2015-07-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2015

## Citation

> AI Analytics. FDA recall D-0288-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0288-2015. Source: US FDA. Licensed CC0.

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