Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0169-2024·Announced 2024-01-03

FDA recalls Asmanex asthma inhalation powder for improper storage conditions

Cardinal Healthcare is recalling Asmanex Twisthaler inhalers (batch U027458) because they were exposed to temperatures outside their labeled storage conditions. The FDA classified this as a Class II recall due to the manufacturing deviation.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: This FDA Class II recall is based on a manufacturing deviation (temperature exposure outside labeled storage conditions) with no reported illnesses or injuries. The recall is precautionary in nature.

Plain-English summary

Cardinal Healthcare is recalling a specific batch of Asmanex Twisthaler inhalation powder (mometasone furoate, 220 mcg per actuation), batch U027458. The recall was initiated because the affected units were exposed to temperatures outside the labeled storage conditions during manufacturing or distribution.

This product is an Rx-only asthma maintenance medication manufactured for Organon LLC. The affected batch consists of 3 units distributed nationwide in the United States.

The FDA has classified this as a Class II recall due to the manufacturing deviation. Patients who have this specific batch should contact their pharmacy or healthcare provider with questions about whether their medication was affected.

Do not stop using your asthma medication without consulting your healthcare provider first, as these are essential maintenance medications. Your healthcare provider can advise you on whether your specific medication is part of the recalled batch and recommend any appropriate next steps.

The recalled product

Product: ASMANEX (MOMETASONE FUROATE)
Brand: ASMANEX
Manufacturer: CARDINAL HEALTHCARE
Category: Drug — Inhaled Corticosteroid
Hazard: storage-temperature-deviation
Affected units: 3

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 (1)

Batch U027458

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by CARDINAL HEALTHCARE 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 42 products in this recall →

Same brand · ASMANEX

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ASMANEX Inhalation Powder Recalled Due to Defective Container
FDA (Drugs) · 2024-06-19
Moderate
Asmanex (Mometasone Furoate) Recalled Due to Defective Container
FDA (Drugs) · 2024-06-19

Same manufacturer · CARDINAL HEALTHCARE

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