# FDA recall D-1138-2015

> **Novartis Pharmaceuticals Corp.** · Class III · drug recall initiated 2015-05-22.

## Product

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,  60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889.  Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

## Reason for recall

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

## Distribution

NJ via 1 distributor

## Key facts

- **Recall number:** D-1138-2015
- **Recalling firm:** Novartis Pharmaceuticals Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-22
- **Report date:** 2015-06-24
- **Termination date:** 2016-05-18

- **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-1138-2015

## Citation

> AI Analytics. FDA recall D-1138-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1138-2015. Source: US FDA. Licensed CC0.

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