Ryaltris Nasal Spray Recalled for Clogged Dip Tube
Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall due to a manufacturing defect (clogged dip tube) that prevents medication delivery. No illnesses or injuries have been reported. The functional defect is a quality issue rather than a safety contamination, falling within the Moderate severity classification for precautionary recalls.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray, 665 mcg/25 mcg per spray, nationwide in the United States.
The dip tube in affected bottles is clogged, which prevents the spray from delivering the medication. This defect prevents patients from receiving their prescribed allergy medication as intended.
The recall involves 45,504 bottles with the following lot numbers and expiration dates: 14230425 (exp Nov-25), 14240024 (exp Dec-25), 14240029 (exp Dec-25), 14240076 (exp Jan-26), 14240082 (exp Jan-26), 14240090 (exp Jan-26), and 14240100 (exp Jan-26). The product was distributed nationwide by Hikma Specialty USA Inc., Columbus, OH.
The recalled product
- Product
- RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE)
- Brand
- RYALTRIS
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Nasal Spray / Allergies
- Affected units
- 45,504
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lots 14230425
- Exp Date
- Nov-25
- 14240024
- Exp Date Dec-25
- 14240029
- 14240076
- Exp Date Jan-26
- 14240082 Exp Date
- Jan-26
- 14240090
- and 14240100
UPCs (1)
- 0359467700276
Distribution
Distributed nationwide across the United States.
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