Novartis Recalls Foradil Aerolizer Capsules Due to Stability Failure
Novartis recalls Foradil Aerolizer (12 mcg) due to failed particle size distribution stability testing. Check lot F0082, exp May 2015.
Recall notice
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Contact the company
What happened, in plain English
Novartis Pharmaceuticals Corp. is recalling Foradil Aerolizer inhalation powder capsules because they failed a stability specification test for particle size distribution. This recall affects 55,442 packs distributed in New Jersey via one distributor. The record does not specify any immediate physical injury risk or provide a remedy for consumers. Read more at govinfonow.com/recall/44668-novartis-pharmaceuticals-corp-recalls-foradil-aerolizer-formoterol-fumarate-inhalation-powder.
Source Summary by GovInfoNow · govinfonow.com/recall/44668-novartis-pharmaceuticals-corp-recalls-foradil-aerolizer-formoterol-fumarate-inhalation-powder · Updated October 12, 2026 · FDA enforcement record: FDA #D-1138-2015
Cite this page
“Novartis Recalls Foradil Aerolizer Capsules Due to Stability Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44668-novartis-pharmaceuticals-corp-recalls-foradil-aerolizer-formoterol-fumarate-inhalation-powder. Based on FDA recall #D-1138-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1138-2015%22&limit=1).
Why it’s dangerous
The product failed to meet stability specifications during testing, resulting in out-of-specification results for the particle size distribution test. The record does not explain how this failure affects the drug's efficacy or safety for the user.
Who’s affected
Patients who have been prescribed Foradil Aerolizer and purchased the affected packs from the specific New Jersey distributor. Individuals with the lot number F0082 and expiration date of May 2015 are specifically impacted.
How to tell if you have this one
Look for Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, sold in packs of 60 capsules (blister strips of 6). Check if the lot number is F0082 and the expiration date is May 2015.
- Brand
Novartis- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
NJ via 1 distributor
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1137-2015 | 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.; Lot #: F8011, Exp May 2015 | 19,658 packs |
| D-1138-2015 | 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.; Lot#: F0082, Exp May 2015 | 55,442 packs |
Where it went and when
Where it was distributed
Distributed in New Jersey.
FDA distribution: “NJ via 1 distributor” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 12 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.
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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-1138-2015 (May 22, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1138-2015 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.