FDA-Drug2026-03-25Class IIPROCESSING DEFECT

Apotex brimonidine/timolol eye drops recalled for sterility concerns

OTHERNationwide distribution

Stop using Apotex brimonidine/timolol eye drops

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
Hazard

Lack of Assurance of Sterility

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-0407-2026

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