FDA Recall D-0407-2026
Apotex Corp. · Weston, FL
Class II Ongoing 70 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0407-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2026-03-05
- Classified by FDA Center
- 2026-03-27
- FDA published
- 2026-03-25
- Recalling firm
- Apotex Corp.
- Firm location
- Weston, FL
Drug identification
- Brand name(s)
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Generic name(s)
- BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Manufacturer(s)
- Apotex Corp.
- NDC(s)
60505-0589- Route(s)
- OPHTHALMIC
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.