FDA Drug recall D-0550-2024
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subs…
- FDA Drug
- Class III
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class III recall of Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subs… by Organon, citing defective Container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0550-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-28 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Organon |
| Distribution | US |
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
Defective Container
Identifiers
| ndc | 78206-114-03 |
|---|---|
| ndc | 78206-114-04 |
| ndc | 78206-114-02 |
| ndc | 78206-114-01 |
| ndc | 78206-114-59 |
| ndc | 78206-115-59 |
| ndc | 78206-115-01 |
| code_info | Lot #: X025346, Exp 3/3/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0550-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.