Moderate riskFDA DrugClass II

Apotex eye drops recalled for lack of sterility assurance

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.

From the FDA notice · Read the official notice ↗ · All Apotex recalls

What to do

  1. Check your eye drop bottle for lot number VJ8599 or VL1668
  2. Do not use the product if it matches either lot number
  3. Contact your pharmacy or doctor for a replacement prescription
  4. Call Apotex Corp. at the number on your bottle if you have questions

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
107,136 vials
Illnesses reported
None reported
Manufactured in
2400 N Commerce Pkwy Ste 400, N/A, Weston, FL, United States
Classification
Class II
Recall number
D-0407-2026

In the FDA's words

Description
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. Lack of Assurance of Sterility Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027 Distribution: U.S. Nationwide Affected quantity: 107,136 vials
Hazard
Lack of Assurance of Sterility

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