Recalls / Class II
Class IID-0006-2025
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.
- Brand name
- Ryaltris
- Generic name
- Olopatadine Hydrochloride And Mometasone Furoate
- Active ingredients
- Mometasone Furoate Monohydrate, Olopatadine Hydrochloride
- Route
- Nasal
- NDC
- 59467-700
- FDA application
- NDA211746
- Affected lot / code info
- 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
Why it was recalled
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- HIKMA SPECIALTY USA INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 45,504 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-09-24
- FDA classified
- 2024-10-03
- Posted by FDA
- 2024-10-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0006-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.