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) 12 mcg per capsule Recalled by Novartis Pharmaceuticals Corp. Due to Failed Stability Specification: out of specification result obtained...

Date: May 22, 2015
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, 12 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.

Quantity: 19,658 packs

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: NJ

Affected (1 state)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