# FDA recall D-0018-2015

> **Valeant Pharmaceuticals North America LLC** · Class III · drug recall initiated 2014-05-21.

## Product

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles  manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada

## Reason for recall

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0018-2015
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-05-21
- **Report date:** 2014-10-22
- **Termination date:** 2015-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2015

## Citation

> AI Analytics. FDA recall D-0018-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0018-2015. Source: US FDA. Licensed CC0.

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