CLASS III ONGOING Drug recall · Reported 19 Jun 2024 · FDA Enforcement Report
Asmanex Twisthaler, mometasone furoate inhalation powder recalled
Organon is recalling Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30, distributed nationwide in the US. The recall was initiated on 28 May 2024 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-0552-2024
- FDA event ID
- 94703
- Recalling firm
- Organon, Jersey City, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 28 May 2024
- FDA classified
- 10 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 28 May 2024 | Recall initiated by company | |
| 10 Jun 2024 | Classified by FDA | +13 days |
| 19 Jun 2024 | 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
Defective Container
Product as listed by the FDA
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Container
Which lots are affected?
Lot #: Y000085, Exp 4/25/2025
Where was it sold?
Nationwide in the USA
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
2 other products · FDA event 94703This product is part of a recall event; the main page for the event is Asmanex Twisthaler, mometasone furoate inhalation powder recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide | |
| CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |
More recalls from Organon
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |
| Drug | CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |