Foradil Aerolizer — Class III drug recall D-1387-2014
Terminated recall by Novartis Pharmaceuticals Corp., reported 2014-06-25, distributed nationwide. Failed Stability Specification; out of specification result for particle size distribution during stability te
| Recall number | D-1387-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., Suffern, NY, United States |
| Recall initiated | 2014-05-28 |
| Classified | 2014-06-17 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-02-12 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00085-1401-01 |
| Lot numbers | 04/15, 06/14, F0067, F0079 |
Product
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
Reason for recall
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1387-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.