Novartis Recalls Foradil Aerolizer Inhalation Powder Due to Stability Failure
Novartis is recalling Foradil Aerolizer inhalation powder because it failed a stability test for particle size distribution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure without reported injuries or illnesses.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule. The recall involves 55,442 packs of the medication, which is distributed in New Jersey via one distributor. The specific lot number is F0082, with an expiration date of May 2015.
The recall was initiated because the product failed a stability specification. Specifically, an out-of-specification result was obtained for the Particle Size Distribution test during stability testing. This indicates that the physical characteristics of the powder may not meet the required standards over time.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The product is a prescription-only medication intended for inhalation use.
The recalled product
- 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…
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Inhalation Powder
- Hazard
- Affected units
- 55,442
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: F0082
- Exp May 2015
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Novartis Pharmaceuticals Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Novartis Pharmaceuticals Corp.
See all →- SevereNovartis Withdraws SANDIMMUNE Oral Solution Bottles Due to Crystallization
FDA (Drugs) · 2023-09-27
- CriticalNovartis Recalls Promacta Oral Suspension Due to Peanut Cross-Contamination
FDA (Drugs) · 2019-05-29
- LowNovartis Recalls Isopto Carpine Eye Drops for Impurity Failures
FDA (Drugs) · 2017-05-03
- ModerateNovartis Recalls Pilocarpine Hydrochloride Ophthalmic Solution for Impurity Failures
FDA (Drugs) · 2017-05-03
- LowNovartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure
FDA (Drugs) · 2015-09-23
Same hazard · stability failure
See all →- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
Similar recalls
- LowNovartis Recalls Foradil Aerolizer Due to Stability Testing Failures
FDA (Drugs) · 2014-06-25
- ModerateFerring Recalls Novarel Injection Due to Missing Anaphylaxis Warning
FDA (Drugs) · 2012-12-12
- LowNovartis Recalls No Doz Max Strength Caffeine Caplets Due to Packaging Defect
FDA (Drugs) · 2013-08-14
- SevereArformoterol Tartrate Inhalation Solution Recall Due to Sterility Assurance
FDA (Drugs) · 2021-09-29
- ModerateAlbuterol inhalers recalled after failing stability specification for particle size distribution
FDA (Drugs) · 2025-08-27
- SevereKroger Specialty Pharmacy Recalls Albuterol Inhalation Solution Due to Processing Controls
FDA (Drugs) · 2018-05-16