Azelastine Nasal Spray (Roxane) – Droplet Size Problem (2016)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Roxane Laboratories, Inc.
Lot Codes / Batch Numbers
Lot # 659365A, Exp 3/31/2018
Products Sold
Lot # 659365A, Exp 3/31/2018
Roxane Laboratories, Inc. is recalling Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL b due to Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point... This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026