Glaucoma eye drops recalled over sterility assurance and bottle sealing concerns
Apotex is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because atypical weight loss from improper bottle sealing raises sterility concerns.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in a sterile ophthalmic product creates an infection risk, and no injuries are reported.
Plain-English summary
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%, in 5 mL and 10 mL bottles, prescription only, manufactured by Apotex Inc. of Richmond Hill, Ontario for Apotex Corp. of Weston, Florida, is being recalled for lack of assurance of sterility. The recall notice attributes this to atypical weight loss caused by improper bottle sealing, which leads to potential sterility concerns.
The recall covers 151,034 bottles. The 5 mL presentation carries NDC 60505-0589-1 and lot VE0614, and the 10 mL presentation carries lot VE0616; both lots expire 12/2025. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an eye drop because the product is applied directly to the ocular surface. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Patients holding the listed lots should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
- Brand
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic solution
- Affected units
- 151,034
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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