Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Azelastine Hydrochloride Nasal Solution (Nasal Spray) Recalled by Roxane Laboratories, Inc. Due to Defective Delivery System: out of specification result for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roxane Laboratories, Inc. directly.
Affected Products
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
Quantity: 74,108 bottles
Why Was This Recalled?
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roxane Laboratories, Inc.
Roxane Laboratories, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report