Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution — Class II drug recall D-0496-2025
Ongoing recall by Apotex Corp., reported 2025-07-02, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0496-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2025-05-28 |
| Classified | 2025-06-25 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 6,288 bottles |
| Reason classes | sterility |
| NDC | 60505-0589, 60505-0589-01, 60505-0589-02, 60505-0589-03 |
| Lot numbers | VC6058 |
| Expiration dates | 2025-10-31 |
Product
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0496-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.