FDA recall D-0407-2026

Apotex Corp. · Class II · drug

Product

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S. Nationwide

Key facts

Status
Ongoing
Initiation date
2026-03-05
Report date
2026-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0407-2026