# FDA recall D-1387-2014

> **Novartis Pharmaceuticals Corp.** · Class III · drug recall initiated 2014-05-28.

## Product

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889,  Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01

## Reason for recall

Failed Stability Specification; out of specification result for particle size distribution during stability testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1387-2014
- **Recalling firm:** Novartis Pharmaceuticals Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-05-28
- **Report date:** 2014-06-25
- **Termination date:** 2015-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suffern, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1387-2014

## Citation

> AI Analytics. FDA recall D-1387-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1387-2014. Source: US FDA. Licensed CC0.

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