Asmanex Twisthaler — Class III drug recall D-0550-2024
Ongoing recall by Organon Llc, reported 2024-06-19, distributed nationwide. Defective Container
| Recall number | D-0550-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Organon Llc, Jersey City, NJ, United States |
| Recall initiated | 2024-05-28 |
| Classified | 2024-06-10 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,886 units |
| Reason classes | packaging |
| NDC | 78206-0114, 78206-0114-01, 78206-0114-02, 78206-0114-03, 78206-0114-04, 78206-0114-59, 78206-0115, 78206-0115-01, 78206-0115-59 |
| Lot numbers | X025346 |
| Expiration dates | 2025-03-03 |
Product
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
Reason for recall
Defective Container
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-0550-2024. 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.