CLASS III Drug recall · Reported 24 Jun 2015 · FDA Enforcement Report
Foradil Aerolizer (formoterol fumarate inhalation powder) recalled
Novartis Pharmaceuticals is recalling Foradil Aerolizer (formoterol fumarate inhalation powder) (Blister strips of per pack, distributed in New Jersey. The recall was initiated on 22 May 2015 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-1137-2015
- FDA event ID
- 71310
- Recalling firm
- Novartis Pharmaceuticals, Suffern, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 May 2015
- FDA classified
- 15 Jun 2015
- Reported
- 24 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 May 2015 | Recall initiated by company | |
| 15 Jun 2015 | Classified by FDA | +24 days |
| 24 Jun 2015 | Published in enforcement report | +9 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 obtained for the Particle Size Distribution test 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, 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.
Where it was distributed
NJ via 1 distributor
Questions about this recall
Why was it recalled?
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Which lots are affected?
Lot #: F8011, Exp May 2015
Where was it sold?
NJ via 1 distributor
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.
Other products in this recall event
1 other product · FDA event 71310This product is part of a recall event; the main page for the event is Foradil Aerolizer (formoterol fumarate inhalation powder) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Foradil Aerolizer (formoterol fumarate inhalation powder) recalled | Novartis Pharmaceuticals | Potency & Assay | NJ |
More recalls from Novartis Pharmaceuticals
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |