PlainRecalls
ModerateClass IIOngoing

FDA Drug recall · Reported October 9, 2024

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.

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

Recall #
D-0006-2025
Affected scope
45,504 bottles
Initiated
September 24, 2024
Verify with FDA Drug →
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Glenmark Pharmaceuticals Inc., USA recalled Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg … - a moderate-severity action.

Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg … was recalled by Glenmark Pharmaceuticals Inc., USA in October 9, 2024. Reason: Defective Delivery System: The dip tube is clogged causing the spray not to work.. Check the official notice for the remedy. Verify recall #D-0006-2025 with the FDA Drug before acting.

The recall

Glenmark Pharmaceuticals Inc., USA issued this moderate-severity FDA Drug recall-Defective Delivery System: The dip tube is clogged causing the spray not to work..

Moderate
severity level
Class II
classification
October 9, 2024
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0006-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Reason for recall

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number D-0006-2025
Date reported October 9, 2024
Date initiated September 24, 2024
Recalling firm Glenmark Pharmaceuticals Inc., USA
Firm location Mahwah, NJ
Affected scope 45,504 bottles
Distribution Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0006-2025) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 45,504 bottles.
Why was this product recalled?
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 9, 2024. Severity: Moderate. Recall number: D-0006-2025.
Where was the recalled product distributed?
Distribution: Nationwide in the USA.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported October 9, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026