Class IIOngoing

Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray recall

FDA recall D-0006-2025 · initiated Sep 24, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Defective Delivery System: The dip tube is clogged causing the spray not to work.

Details

Product: Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
Recalling company: Glenmark Pharms
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Sep 24, 2024
FDA report date: Oct 9, 2024

This recall is linked to a product we cover: Ryaltris →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0006-2025 ↗

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