Asmanex Twisthaler inhalation powder recalled due to defective container
Organon LLC is recalling Asmanex Twisthaler (mometasone furoate) inhalation powder nationwide due to defective containers. Affected lot #Y000085 expires April 25, 2025.
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: FDA Class III classification with no reported illnesses or injuries. This voluntary, precautionary recall for a container defect qualifies as Moderate (2), within the typical 1-2 range for Class III recalls.
Plain-English summary
Organon LLC is recalling Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses) nationwide due to defective containers. The recall was initiated on May 28, 2024.
The affected lot is #Y000085, with an expiration date of April 25, 2025. This voluntary Class III recall applies to all units of this lot distributed nationwide. The defective container may prevent proper delivery of the medication.
Patients using this medication should contact their healthcare provider about the recall. For additional information, patients and healthcare providers can contact Organon LLC or the FDA.
The recalled product
- Product
- 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
- Manufacturer
- Organon Llc
- Category
- Drug — Inhalation Powder
- Hazard
- defective-container
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 #: Y000085
- Exp 4/25/2025
Distribution
Distributed nationwide across the United States.
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