Apotex Corp.: Drug Recall

Recall #D-0495-2025 · 05/28/2025

Class II: Risk

Recall Details

Recall Number: D-0495-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Apotex Corp.
Status: Ongoing
Date Initiated: 05/28/2025
Location: Weston, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 105,456 Bottles

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

US Nationwide.

Other Recalls by Apotex Corp.

Class II: Risk 09/05/2025

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 09/05/2025

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 05/28/2025

Lack of Assurance of Sterility
Class II: Risk 05/28/2025

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II: Risk 05/28/2025

Lack of Assurance of Sterility

View all recalls by Apotex Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.