Class II · Moderate risk
Azelastine HCl Ophthalmic Solution
Lack of Assurance of Sterility
Is Azelastine recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Azelastine (9 total). Check the affected lots below.
Most common reason: Packaging defect (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azelastine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Azelastine recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Azelastine Hydrochloride Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class III · Low risk
Azelastine HCl Ophthalmic Solution 0.05%
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class III · Low risk
Azelastine HCl Nasal Solution
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
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class II · Moderate risk
Azelastine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Azelastine HCl Nasal Solution
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
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