FDA-Drug2026-03-25Class IIPROCESSING DEFECT
Apotex brimonidine/timolol eye drops recalled for sterility concerns
What this means
Apotex Corp. is recalling specific lots of brimonidine tartrate/timolol maleate eye drops because the manufacturer cannot confirm the product was sterilized properly. The affected lots are VJ8599 (expires 09/30/2026) and VL1668 (expires 01/31/2027). No infections or injuries have been reported so far.
- Check your eye drop bottle for lot number VJ8599 or VL1668
- Do not use the product if it matches either lot number
- Contact your pharmacy or doctor for a replacement prescription
- Call Apotex Corp. at the number on your bottle if you have questions
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
107,136 vials
Manufactured in
2400 N Commerce Pkwy Ste 400, N/A, Weston, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0407-2026Want us to check the next one for you?
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