# FDA recall D-0798-2021

> **Viatris** · Class III · drug recall initiated 2021-09-13.

## Product

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

## Reason for recall

Failed Impurities/Degradation Specifications; out of specification for Related Compound

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0798-2021
- **Recalling firm:** Viatris
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-13
- **Report date:** 2021-09-22
- **Termination date:** 2022-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0798-2021

## Citation

> AI Analytics. FDA recall D-0798-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0798-2021. Source: US FDA. Licensed CC0.

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