Asmanex Twisthaler recall
FDA recall D-0550-2024 · initiated May 28, 2024
Organon Llc recalled Asmanex Twisthaler in May 2024 — an FDA Class III recall (D-0550-2024) because Defective Container.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Defective Container
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,886 units
Details
- 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
- Recalling company
- Organon USA LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 28, 2024
- FDA report date
- Jun 19, 2024
This recall is linked to a product we cover: Asmanex Twisthaler →
Frequently asked
- Was Asmanex Twisthaler recalled?
- Organon Llc recalled Asmanex Twisthaler in May 2024 — an FDA Class III recall (D-0550-2024) because Defective Container. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Asmanex Twisthaler recalled?
- Per the FDA enforcement record, the reason for recall D-0550-2024 was: Defective Container
- Is a recalled Asmanex Twisthaler dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Asmanex Twisthaler are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: X025346, Exp 3/3/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0550-2024.