Stop using nowDrug recall · FDA · Published March 5, 2026
Apotex Brimonidine/Timolol Eye Drops Recall: Lack of Sterility Risk
Apotex recalls 5mL prescription eye drops (0.2%/0.5%) due to lack of sterility assurance. This could cause infections if used improperly. Check NDC 60505-0589-1 and lots VJ8599 or VL1668.
“Apotex Brimonidine/Timolol Eye Drops Recall: Lack of Sterility Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31452-apotex-brimonidine-timolol-eye-drops-recall-lack-of-sterility-risk. Based on FDA recall #D-0407-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0407-2026%22&limit=1).
The FDA announced on March 5, 2026, that Apotex Corp. is voluntarily recalling Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution due to a lack of assurance of sterility. The recall affects 107,136 vials distributed nationwide.
Lots: VJ8599 (Exp Date 09/30/2026), VL1668 (Exp Date 01/31/2027)
Quantity: 107,136 vials
The hazard
The product lacks assurance of sterility. According to FDA's FAERS database, there are 52 adverse-event reports naming this product, including 25 marked serious and 2 listing a death.
Context
GovInfoNow's records show Apotex Corp. has 23 other recalls on record since 2007-06-14. Other recent recalls of similar products include Clear Eyes Eye Drops Recall (2026-09-15), K.C. Pharmaceuticals Ultra Lubricating Eye Drops Recall (2026-03-03) and K.C. Pharmaceuticals Sterile Eye Drops AC Recall (2026-03-03). Apotex also issued a recall for Paxil CR 37.5mg Tablets on 2026-08-13 due to failed dissolution specifications. On 2026-04-08, Apotex recalled Desmopressin Nasal Spray because of defective bottle caps.
How to tell if you have this one
Check the product label for 'Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%', 5 mL, Rx Only. Look for NDC 60505-0589-1 and lots VJ8599 or VL1668.
Brand
Apotex
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled eye drops as they may not be sterile and could cause infections.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0407-2026 (March 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0407-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.