Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray recall
FDA recall D-0006-2025 · initiated Sep 24, 2024
Glenmark Pharmaceuticals Inc., USA recalled Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray in Sep 2024 — an FDA Class II recall (D-0006-2025) because Defective Delivery System: The dip tube is clogged causing the spray not to work.
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.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 45,504 bottles
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 →
Frequently asked
- Was Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray in Sep 2024 — an FDA Class II recall (D-0006-2025) because Defective Delivery System: The dip tube is clogged causing the spray not to work. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray recalled?
- Per the FDA enforcement record, the reason for recall D-0006-2025 was: Defective Delivery System: The dip tube is clogged causing the spray not to work.
- Is a recalled Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0006-2025.