Class IIOngoing

Azelastine HCl Ophthalmic Solution recall

FDA recall D-0495-2025 · initiated May 28, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility

Details

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
Recalling company: Apotex
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: May 28, 2025
FDA report date: Jul 2, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0495-2025 ↗

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