Akorn, Inc. is recalling 8,574 bottles of Azelastine HCl Ophthalmic Solution 0.05% (generic Optivar) eye drops because laboratory testing discovered out-of-specification results for an impurity called Azelastine N-oxide. This means the medication has begun to degrade or contains higher levels of chemical impurities than safety standards allow. The recall affects 6 mL bottles sold in individual boxes nationwide, and consumers should check their medication immediately to see if it belongs to the affected lots.
The presence of impurities beyond the approved specifications indicates that the drug may not maintain its intended potency or safety profile over time. Using medication that has degraded or contains excessive impurities could lead to reduced effectiveness or unexpected side effects when treating eye symptoms.
Refund and medical guidance
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Sources: FDA iRES · Raw API Response
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