Foradil Aerolizer — Class III drug recall D-1138-2015
Terminated recall by Novartis Pharmaceuticals Corp., reported 2015-06-24, distributed in NJ. Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test d
| Recall number | D-1138-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., Suffern, NY, United States |
| Recall initiated | 2015-05-22 |
| Classified | 2015-06-15 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-05-18 |
| Distributed | NJ |
| Quantity | 55,442 packages |
| Reason classes | specification failure |
| Lot numbers | F0082 |
| Expiration dates | 2015-05-20 |
Product
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.
Reason for recall
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test 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-1138-2015. 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.