# FDA recall D-0506-2019

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-02-13.

## Product

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505

## Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

## Distribution

Throughout the United States

## Key facts

- **Recall number:** D-0506-2019
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-13
- **Report date:** 2019-02-27
- **Termination date:** 2019-09-12

- **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-0506-2019

## Citation

> AI Analytics. FDA recall D-0506-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0506-2019. Source: US FDA. Licensed CC0.

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