Apotex Recalls Brimonidine/Timolol Ophthalmic Solution Over Sterility Concerns

Apotex Corp has initiated a voluntary nationwide recall of brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, a sterile, prescription ophthalmic product packaged in 5 mL vials (NDC 60505-0589-1). The recall affects more than 107 000 units distributed across the US, specifically lots VJ8599 (expiration September 30, 2026) and VL1669 (expiration January 31, 2027). The firm notified consignees via letter beginning March 5, 2026, and the recall remains ongoing.

The US Food and Drug Administration (FDA) has not yet assigned a formal recall classification to this event. It is categorized as a voluntary, firm-initiated recall and is currently listed as ongoing with no termination date or classification decision from the agency. No press release has been issued, which is not uncommon for recalls still under evaluation or pending classification. Pharmacists should monitor updates from the FDA Enforcement Report for any changes in classification, as this will indicate the level of patient risk.

The recall was initiated due to a lack of assurance of sterility, a critical quality concern for ophthalmic products that may pose a risk of eye infections or other adverse events if contaminated. Apotex Corp, based in Weston, Florida, is responsible for the recall. For clinical context, the combination of brimonidine tartrate (an alpha-2 adrenergic agonist) and timolol maleate (a beta-blocker) is indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension, making sterility essential for patient safety in routine ophthalmic use.

Reference

FDA. Enforcement Report. March 5, 2026. Accessed March 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219000