Use caution Drug recall · FDA · Published March 1, 2023

Apotex Brimonidine Ophthalmic Solution 0.15% Recall: Cap Cracks Risk Sterility

Apotex recalls Brimonidine Tartrate Ophthalmic Solution 0.15% (Rx only) due to cap cracks that may compromise sterility. Affected units have specific NDC/UPC codes and expiration dates. Consumers should contact Apotex for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0433-2023Drug Apotex ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmApotex Corp.2400 N Commerce Pkwy Ste 400 · Weston, FL 33326-3253

✎ GovInfoNow plain-language explainer

Apotex is recalling Brimonidine Tartrate Ophthalmic Solution 0.15% (Rx only) because some bottles have cracks in the cap that could allow contamination. This poses a risk of infection if the medication is not sterile. Read more at govinfonow.com/recall/33837-apotex-brimonidine-ophthalmic-solution-0-15-recall-cap-cracks-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33837-apotex-brimonidine-ophthalmic-solution-0-15-recall-cap-cracks-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0433-2023

Cite this page

“Apotex Brimonidine Ophthalmic Solution 0.15% Recall: Cap Cracks Risk Sterility.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33837-apotex-brimonidine-ophthalmic-solution-0-15-recall-cap-cracks-risk. Based on FDA recall #D-0433-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0433-2023%22&limit=1).

Apotex Corp. recalled Brimonidine Tartrate Ophthalmic Solution 0.15% on March 1, 2023, due to a lack of sterility assurance caused by cracked bottle caps, the FDA said. Owners should contact Apotex for a refund.

How to tell if you have it

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only
5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5
10 mL dropper bottle, NDC 60505-0564-2, UPC 3 60505 05642 2
15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9
Lots TJ9848, TJ9849, TK0258, TK5341, TK0261, TK0262

The hazard

Cracks have developed in some of the unit caps of Brimonidine tartrate ophthalmic solution bottles, creating a possibility that the broken cap may impact sterility. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Apotex Corp. has 24 other recalls on record since 2007-06-14. Recent similar recalls include the BD ChloraPrep FREPP Clear 1.5mL Applicator recall (2026-05-28) and the K.C. Pharmaceuticals Sterile Eye Drops AC Recall (2026-03-03). Other recent recalls of similar products include the BD ChloraPrep Clear 60x1mL recall (2026-07-09).

How to tell if you have this one

Check for bottles labeled 'Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only' with specific NDC numbers: 60505-0564-1 (5mL), 60505-0564-2 (10mL), or 60505-0564-3 (15mL). The expiration dates for these units range from February 2024 to April 2024.

Brand
Apotex
Product
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Bottle Details
Identify the NDC code on the bottle (60505-0564-1, 60505-0564-2, or 60505-0564-3) and expiration date.
Contact Apotex
Reach out to Apotex for instructions on how to return or replace the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 14 days after the firm started it.

Mar 1, 2023Firm started the recall
Mar 3, 2023FDA classified it Class II
Mar 15, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Apotex recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33837-apotex-brimonidine-ophthalmic-solution-0-15-recall-cap-cracks-risk">Apotex Brimonidine Ophthalmic Solution 0.15% Recall: Cap Cracks Risk Sterility (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0433-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0433-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.