# FDA recall D-1032-2016

> **Valeant Pharmaceuticals North America LLC** · Class III · drug recall initiated 2016-05-23.

## Product

Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ  08807, UPC 0 00950 86006 8.

## Reason for recall

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1032-2016
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-23
- **Report date:** 2016-06-22
- **Termination date:** 2017-09-12

- **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-1032-2016

## Citation

> AI Analytics. FDA recall D-1032-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1032-2016. Source: US FDA. Licensed CC0.

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