Apotex Recalls Brimonidine/Timolol Ophthalmic Solution Over Sterility Concerns

Apotex Corp. has initiated a Class II recall of brimonidine tartrate/timolol maleate ophthalmic solution, 0.2%/0.5%, a prescription eye drop used to lower intraocular pressure. The affected product includes 5 mL and 10 mL bottles (NDC 60505-0589-1 and 60505-0589-2) manufactured by Apotex Inc. in Richmond Hill, Ontario, and distributed nationwide in the United States by Apotex Corp., Weston, Florida. The recall affects lot numbers VE0614 and VE0616, both with an expiration date of December 2025. Approximately 151 034 bottles are impacted.

The recall was initiated voluntarily by the company on September 5, 2025, following discovery of atypical bottle weight loss due to improper sealing. This defect raises a potential risk to sterility, creating the possibility of microbial contamination. Although no press release was issued, the recall remains ongoing under US Food and Drug Administration (FDA) oversight, and affected consignees were notified by letter. The FDA formally classified the recall as Class II on September 30, 2025, meaning use of the product could cause temporary or medically reversible adverse health consequences, though the probability of serious harm is remote.

Brimonidine tartrate/timolol maleate ophthalmic solution is a combination medication indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Brimonidine decreases fluid production and increases uveoscleral outflow, while timolol, a beta-blocker, reduces aqueous humor formation. Pharmacists should ensure patients using Apotex’s combination eye drops are informed of the recall and advised to check lot numbers to prevent potential exposure to compromised sterile products.

Reference

FDA. Enforcement Report. October 8, 2025. Accessed October 8, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=215926