Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Foradil Aerolizer (formoterol fumarate inhalation powder) Recalled by Novartis Pharmaceuticals Corp. Due to Failed Stability Specification; out of specification result for...

Date: May 28, 2014
Company: Novartis Pharmaceuticals Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novartis Pharmaceuticals Corp. directly.

Affected Products

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

Quantity: Lot F0067: 45,834 units; Lot F0079: 63,321 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novartis Pharmaceuticals Corp.

Novartis Pharmaceuticals Corp. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report