# FDA recall D-1116-2015

> **Valeant Pharmaceuticals North America LLC** · Class II · drug recall initiated 2015-04-17.

## Product

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

## Reason for recall

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

## Distribution

United States Nationwide

## Key facts

- **Recall number:** D-1116-2015
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-17
- **Report date:** 2015-06-17
- **Termination date:** 2016-04-12

- **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-1116-2015

## Citation

> AI Analytics. FDA recall D-1116-2015. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1116-2015. Source: US FDA. Licensed CC0.

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