Novartis Recalls Foradil Aerolizer Due to Stability Issues
Novartis recalls specific lots of Foradil Aerolizer inhalation powder due to failed stability specifications. Check your lot numbers immediately.
Recall notice
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Contact the company
What happened, in plain English
Novartis Pharmaceuticals Corp. is recalling specific lots of Foradil Aerolizer (formoterol fumarate inhalation powder) because the product failed stability specifications during testing. The issue involves an out-of-specification result for particle size distribution. This recall affects units distributed nationwide. Read more at govinfonow.com/recall/46025-novartis-pharmaceuticals-corp-recalls-foradil-aerolizer-formoterol-fumarate-inhalation-powder.
Source Summary by GovInfoNow · govinfonow.com/recall/46025-novartis-pharmaceuticals-corp-recalls-foradil-aerolizer-formoterol-fumarate-inhalation-powder · Updated October 12, 2026 · FDA enforcement record: FDA #D-1387-2014
Cite this page
“Novartis Recalls Foradil Aerolizer Due to Stability Issues.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/46025-novartis-pharmaceuticals-corp-recalls-foradil-aerolizer-formoterol-fumarate-inhalation-powder. Based on FDA recall #D-1387-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1387-2014%22&limit=1).
Why it’s dangerous
The recall was initiated because the product failed stability specifications, specifically regarding particle size distribution during stability testing. The record does not explicitly state what health risks result from this failure, only that the specification was not met.
Who’s affected
Patients who have been prescribed Foradil Aerolizer and possess the specific lots listed in the record are affected. Individuals using these specific expired or near-expired capsules may be at risk if the medication's efficacy is compromised.
How to tell if you have this one
Check your inhaler capsules for the following details: Product name Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules. Look for NDC 0085-1401-01. Identify if you have Lot F0067 with expiration date 06/14 or Lot F0079 with expiration date 04/15.
- Brand
Novartis- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the recalled product is 0085-1401-01.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1387-2014 (May 28, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1387-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.