Medications & Supplements/Prescription Drugs

Asmanex Twisthaler Inhalation Powder Recalled for Defective Containers

Agency Publication Date: June 10, 2024

Summary

Organon LLC has recalled 5,437 units of Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation. The recall affects 14, 30, and 60-metered dose sizes because the containers are defective, which may impact how the medication is stored or delivered. If you use this medication, contact your healthcare provider or pharmacist for guidance regarding your treatment.

Risk

A defective container can compromise the integrity of the medication or prevent the device from delivering the correct dose. This could lead to a patient receiving less medication than intended for their respiratory condition.

What You Should Do

This recall affects Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation, in 14-dose, 30-dose, and 60-dose containers.
Check your packaging for the following lot numbers and NDC codes: Lot Y000085 (Exp 4/25/2025) with NDC 78206-0114-04; Lot X025346 (Exp 3/3/2025) with NDC 78206-114-02; or Lot X024051 (Exp 04/25/2025) with NDC 78206-114-03.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Organon LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation (30 Metered Doses)

Variants: 220 mcg per actuation, 30 Metered Doses, Inhalation Powder

Lot Numbers:

Y000085 (Exp 4/25/2025)

NDC:

78206-0114-04

Rx Only. Product of Singapore.

Product: Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation (60 Metered Doses)

Variants: 220 mcg per actuation, 60 Metered Doses, Inhalation Powder

Lot Numbers:

X025346 (Exp 3/3/2025)

NDC:

78206-114-02

Rx Only. Product of Singapore.

Product: Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation (14 Metered Doses)

Variants: 220 mcg per actuation, 14 Metered Doses, Inhalation Powder

Lot Numbers:

X024051 (Exp 04/25/2025)

NDC:

78206-114-03

Rx Only. Product of Singapore.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94703

Status: Active

Manufacturer: Organon Llc

Sold By: Pharmacies

Manufactured In: Singapore, United States

Units Affected: 3 products (2,886 units; 2,551 units; 0)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation, in 14-dose, 30-dose, and 60-dose containers.

Check your packaging for the following lot numbers and NDC codes: Lot Y000085 (Exp 4/25/2025) with NDC 78206-0114-04; Lot X025346 (Exp 3/3/2025) with NDC 78206-114-02; or Lot X024051 (Exp 04/25/2025) with NDC 78206-114-03.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Organon LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation (30 Metered Doses)

Variants: 220 mcg per actuation, 30 Metered Doses, Inhalation Powder

Lot Numbers:

Y000085 (Exp 4/25/2025)

NDC:

78206-0114-04

Rx Only. Product of Singapore.

Product: Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation (60 Metered Doses)

Variants: 220 mcg per actuation, 60 Metered Doses, Inhalation Powder

Lot Numbers:

X025346 (Exp 3/3/2025)

NDC:

78206-114-02

Rx Only. Product of Singapore.

Product: Asmanex Twisthaler (mometasone furoate inhalation powder), 220 mcg per actuation (14 Metered Doses)

Variants: 220 mcg per actuation, 14 Metered Doses, Inhalation Powder

Lot Numbers:

X024051 (Exp 04/25/2025)

NDC:

78206-114-03

Rx Only. Product of Singapore.