Sun Pharmaceutical Industries, Inc. recalls Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% (30mL) due to droplet size test failure during stability testing. This may affect drug consistency but does not pose immediate safety risks.
Lower-risk recall
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling a specific nasal spray medication because it failed a droplet size test during long-term stability testing. This issue could affect how the medication performs but does not indicate an immediate safety risk to users. Read more at govinfonow.com/recall/40888-sun-pharmaceutical-azelastine-nasal-spray-recall-droplet-size-test-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/40888-sun-pharmaceutical-azelastine-nasal-spray-recall-droplet-size-test-failure · Updated October 7, 2026 · FDA enforcement record: FDA #D-0417-2018
Cite this page
“Sun Pharmaceutical Azelastine Nasal Spray Recall: Droplet Size Test Failure.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40888-sun-pharmaceutical-azelastine-nasal-spray-recall-droplet-size-test-failure. Based on FDA recall #D-0417-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0417-2018%22&limit=1).
Why it’s dangerous
The medication failed a droplet size test during a 6-month stability study. This could mean the spray may not deliver medication as consistently as intended, but does not indicate immediate safety risks.
Who’s affected
Patients prescribed this nasal spray medication by a healthcare provider. Those with specific medical conditions requiring precise medication delivery may be most affected.
How to tell if you have this one
Look for the product name 'Azelastine HCl Nasal Solution 0.1% (30 mL)' with NDC 47335-779-91. The product was distributed by Sun Pharmaceutical starting in November 2018.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Verify the product label shows 'Azelastine HCl Nasal Solution 0.1% (30 mL)' with NDC 47335-779-91.
Questions people ask
Is this product dangerous?
No immediate safety risks are reported. The recall is due to a test failure in drug consistency, not a safety hazard.
What should I do if I have this product?
The recall does not specify a remedy. Check the product details and contact your healthcare provider for guidance.
When was this product distributed?
The product was distributed starting in November 2018.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0417-2018 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0417-2018 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0417-2018 (February 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0417-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.