Asmanex (Mometasone Furoate) Recalled Due to Defective Container
Organon LLC has voluntarily recalled 2,886 units of Asmanex inhalation powder nationwide due to defective containers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a defective container, a packaging defect. As a voluntary precautionary recall, this fits the Moderate (2) category per the rubric.
Plain-English summary
Organon LLC has initiated a voluntary recall of 2,886 units of Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation) due to defective containers. The affected product is lot #X025346, with an expiration date of March 3, 2025.
The affected product was distributed nationwide in the United States. Patients currently using Asmanex from the recalled lot should contact their healthcare provider or pharmacist regarding this recall and obtain unaffected replacement product.
No illnesses or injuries have been reported at this time. The recall was initiated voluntarily by Organon LLC as a precautionary measure.
The recalled product
- Product
- ASMANEX (MOMETASONE FUROATE)
- Brand
- ASMANEX
- Manufacturer
- Organon Llc
- Category
- Drug
- Hazard
- Affected units
- 2,886
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: X025346
- Exp 3/3/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Organon Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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