# FDA recall D-0659-2016

> **Sandoz Inc** · Class III · drug recall initiated 2015-12-31.

## Product

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

## Reason for recall

Failed Impurities/Degradation Specifications; 9 month stability timepoint

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0659-2016
- **Recalling firm:** Sandoz Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-31
- **Report date:** 2016-02-17
- **Termination date:** 2017-04-12

- **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-0659-2016

## Citation

> AI Analytics. FDA recall D-0659-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0659-2016. Source: US FDA. Licensed CC0.

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