Roxane Azelastine Nasal Spray Recall: Defective Delivery System Risk
Roxane Laboratories recalls 0.1% Azelastine Hydrochloride Nasal Solution (30mL bottles) due to potential delivery issues. Rx-only product with specific lot number and expiration date.
Recall notice
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Contact the company
What happened, in plain English
Roxane Laboratories is recalling 0.1% Azelastine Hydrochloride Nasal Solution (30mL bottles) because of a defective delivery system that may cause inconsistent dosing. This recall affects prescription-only nasal spray products with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/42128-roxane-azelastine-nasal-spray-recall-defective-delivery-system-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42128-roxane-azelastine-nasal-spray-recall-defective-delivery-system-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0448-2017
Cite this page
“Roxane Azelastine Nasal Spray Recall: Defective Delivery System Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42128-roxane-azelastine-nasal-spray-recall-defective-delivery-system-risk. Based on FDA recall #D-0448-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0448-2017%22&limit=1).
Why it’s dangerous
The product's droplet size distribution failed testing at the 6-month mark, which could lead to inconsistent medication delivery. This defect might cause the nasal spray to not deliver the correct dose of medication as intended.
Who’s affected
Prescription-only nasal spray users who purchased the specific 30mL bottles with lot #659365A (expiring 3/31/2018) are affected. Patients using this product for allergies may be at risk if the delivery system causes inconsistent dosing.
How to tell if you have this one
Check for the 30mL bottle with lot number 659365A and expiration date 3/31/2018. This prescription-only nasal spray was distributed by West-Ward Pharmaceuticals Corp. in New Jersey.
- Brand
Roxane Laboratories- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the product label to confirm if it matches lot #659365A expiring 3/31/2018.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0448-2017 (December 14, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0448-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.