CLASS II Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report

Brimonidine Tartrate Ophthalmic Solution recalled by Apotex

Apotex is recalling Brimonidine Tartrate Ophthalmic Solution 0.15%, distributed nationwide in the US. The recall was initiated on 1 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024

Quantity recalled67,056 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0433-2023
FDA event ID: 91803
Recalling firm: Apotex, Weston, FL
Classification: Class II
Status: Completed
Recall initiated: 1 Mar 2023
FDA classified: 3 Mar 2023
Reported: 15 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Eye Drops

Timeline

1 Mar 2023	Recall initiated by company
3 Mar 2023	Classified by FDA	+2 days
15 Mar 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

Which lots are affected?

Lots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 8 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Apotex

All 75

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled	Apotex	Other	Nationwide
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide

Other Brimonidine recalls

All 9

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Potency & Assay	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Potency & Assay	Nationwide