Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azelastine HCl Ophthalmic Solution Recalled by Apotex Corp. Due to Lack of Assurance of Sterility
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 Apotex Corp. directly.
Affected Products
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Quantity: 105,456 Bottles
Why Was This Recalled?
Lack of Assurance of Sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Apotex Corp.
Apotex Corp. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report