Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Asmanex Twisthaler (Mometasone Furoate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
Affected NDC
78206-0114-02
Compare with the code on your package — it is the most precise check available.
Drug: Mometasone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Asmanex Mometasone Furoate NDC 78206-0114 |
220 ug/1 | Inhalant Respiratory (inhalation) |
Organon LLC | Rx |
- Recalling firm
- Organon Llc
- NDC code
- 78206-114-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0550-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Mometasone recalls
See all
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class III · Low risk
Mometasone Furoate
Defective Container
Other recalls by Organon Llc
All 2024 recalls
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.