Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Is Mometasone recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Mometasone (14 total). Check the affected lots below.
Most common reason: Packaging defect (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mometasone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mometasone recalls on record
none so far in 2026; 14 on record, newest first
Class III · Low risk
Asmanex Twisthaler
Defective Container
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
Class II · Moderate risk
Asmanex Twisthaler
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Mometasone Furoate Topical Solution
CGMP Deviaitons
Class II · Moderate risk
Mometasone Furoate Cream USP
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Class III · Low risk
Mometasone Furoate Cream
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Class II · Moderate risk
Glenmark Mometasone Furoate Cream
CGMP Deviations: Market complaints related to "gritty texture".
Class III · Low risk
Mometasone Furoate Ointment USP
Subpotent drug
Class II · Moderate risk
Mometasone Furoate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Mometasone 0.6 mg /60 mL Irrigation solution
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
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