Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f
Summary
The FDA issued a Class II for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx On by Apotex Corp.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0407-2026
Action Date
2026-03-25
Status
Ongoing
Category
drug
Product 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.
Lot/Code Info: Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Quantity Affected: 107,136 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-05
Company
Weston, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apotex Corp. has 19 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apotex Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apotex Corp. have FDA actions?
Apotex Corp. has 19 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0407-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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