ASMANEX Inhalation Powder Recalled Due to Defective Container
Organon LLC is recalling 2,551 units of ASMANEX Twisthaler mometasone furoate inhalation powder nationwide due to defective containers. Affected lot X024051 expires April 25, 2025.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall for a container defect with no reported illnesses or injuries. The defect relates to packaging integrity rather than the drug formulation itself, and the recall is voluntary and precautionary.
Plain-English summary
ASMANEX Twisthaler (mometasone furoate) inhalation powder, 220 micrograms per actuation, is being recalled due to defective containers. Organon LLC initiated this voluntary recall on May 28, 2024, after identifying the issue. The recalled product includes lot number X024051 with an expiration date of April 25, 2025.
The recall affects 2,551 units distributed nationwide in the United States. Patients using ASMANEX from the affected lot should consult their healthcare provider or pharmacist about their medication.
The FDA classified this as a Class III recall. Organon LLC, a subsidiary of Organon & Co., manufactures the product in Singapore. The company notified customers by letter.
The recalled product
- Product
- ASMANEX (MOMETASONE FUROATE)
- Brand
- ASMANEX
- Manufacturer
- Organon Llc
- Category
- Drug — Inhalation Medication
- Hazard
- Affected units
- 2,551
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 #: X024051
- Exp 04/25/2025
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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Same manufacturer · Organon Llc
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FDA (Drugs) · 2024-06-19
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