CLASS II ONGOING Drug recall · Reported 9 Oct 2024 · FDA Enforcement Report

Ryaltris (olopatadine hydrochloride recalled by Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Inc., USA is recalling Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg, distributed nationwide in the US. The recall was initiated on 24 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 14230425, Exp Date, Nov-25; 14240024, Exp Date Dec-25; 14240029, Exp Date Dec-25; 14240076, Exp Date Jan-26; 14240082 Exp Date, Jan-26, 14240090, Exp Date Jan-26; and 14240100, Exp Date Jan-26

NDC59467-700

UPC0359467700276

Quantity recalled45,504 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0006-2025
FDA event ID: 95389
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Brand: Ryaltris
Manufacturer: HIKMA SPECIALTY USA INC.
Classification: Class II
Status: Ongoing
Recall initiated: 24 Sep 2024
FDA classified: 3 Oct 2024
Reported: 9 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Eye Drops

Timeline

24 Sep 2024	Recall initiated by company
3 Oct 2024	Classified by FDA	+9 days
9 Oct 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lots 14230425, Exp Date, Nov-25; 14240024, Exp Date Dec-25; 14240029, Exp Date Dec-25; 14240076, Exp Date Jan-26; 14240082 Exp Date, Jan-26, 14240090, Exp Date Jan-26; and 14240100, Exp Date Jan-26

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Olopatadine recalls

All 12

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled	USV Private	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Olopatadine HCl Nasal Spray, 665 mcg recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Olopatadine HCl Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Olopatadine HCl Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Olopatadine HCl Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide