CLASS III Drug recall · Reported 25 Jun 2014 · FDA Enforcement Report
Foradil Aerolizer (formoterol fumarate inhalation powder) recalled
Novartis Pharmaceuticals is recalling Foradil Aerolizer (formoterol fumarate inhalation powder), distributed nationwide in the US. The recall was initiated on 28 May 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1387-2014
- FDA event ID
- 68282
- Recalling firm
- Novartis Pharmaceuticals, Suffern, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 May 2014
- FDA classified
- 17 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 May 2014 | Recall initiated by company | |
| 17 Jun 2014 | Classified by FDA | +20 days |
| 25 Jun 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Which lots are affected?
Lot F0067 exp. 06/14, F0079 exp. 04/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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