# FDA recall D-66403-009

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2013-09-13.

## Product

Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***

## Reason for recall

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-66403-009
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-13
- **Report date:** 2013-11-13
- **Termination date:** 2015-07-23

- **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-66403-009

## Citation

> AI Analytics. FDA recall D-66403-009. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-66403-009. Source: US FDA. Licensed CC0.

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