# FDA recall D-0151-2017

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2016-11-03.

## Product

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA

## Reason for recall

Failed Impurities/Degradation Specifications: OOS results for known compound.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0151-2017
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-03
- **Report date:** 2016-11-30
- **Termination date:** 2017-08-01

- **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-0151-2017

## Citation

> AI Analytics. FDA recall D-0151-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0151-2017. Source: US FDA. Licensed CC0.

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