FDA Recall D-0006-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 597 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 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

Quantity: 45,504 bottles

Reason for recall

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

Recall record

Recall number: D-0006-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-09-24
Classified by FDA Center: 2024-10-03
FDA published: 2024-10-09
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): RYALTRIS
Generic name(s): OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
Manufacturer(s): HIKMA SPECIALTY USA INC.
NDC(s): 59467-700
Route(s): NASAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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