Apotex Corp. recalls Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,
Recalled July 2, 2025 · FDA recall D-0495-2025 · Apotex
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
105,456 Bottles
Sold at
US Nationwide.
Description
Lack of Assurance of Sterility
Product
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
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →