Mometasone Furoate recalls: 6 FDA reports
Recalls involving Mometasone Furoate. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
2Ongoing
2024-06-19Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Ma
D-0551-2024 · Class III · reported 2024-06-19 · Ongoing
- Why it was recalled
- Defective Container
- Product
- Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
- Where it went
- Nationwide in the USA
- How much
- 2,551 units
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Ma
D-0550-2024 · Class III · reported 2024-06-19 · Ongoing
- Why it was recalled
- Defective Container
- Product
- 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
- Where it went
- Nationwide in the USA
- How much
- 2,886 units
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only,
D-0169-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
- Where it went
- Nationwide USA
- How much
- 3 units
SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams D
D-0167-2023 · Class III · reported 2023-01-25 · Terminated
- Why it was recalled
- Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
- Product
- SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.
- Where it went
- Nationwide
- How much
- 9898 pouches
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (N
D-1173-2022 · Class III · reported 2022-07-13 · Terminated
- Why it was recalled
- Defective Container
- Product
- Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.
- Where it went
- Nationwide in the USA
- How much
- 98, 307 packs
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 6
D-1586-2019 · Class II · reported 2019-08-14 · Terminated
- Why it was recalled
- GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
- Product
- Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Where it went
- Nationwide within the United States
- How much
- N/A
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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