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Mark C. Howell Jr., Ph.D.
Edited By : Amy Edel
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Why Did Apotex Recall Its Eye Drops?

Apotex Corp. has taken the necessary steps, under the guidance of the U.S. Food and Drug Administration, to voluntarily recall six specific lots of 0.15% brimonidine tartrate ophthalmic solution. Brimonidine tartrate ophthalmic solution is an alpha-adrenergic receptor agonist. Its primary function is to reduce elevated intraocular pressure and the risk of progression and vision loss.

Safety-related concerns drove the decision to initiate the recall of Apotex eye drops after the observation of cracks in the caps of certain bottles of the Apotex product. It was essential to address the issue promptly to ensure the solution remains sterile.

Key facts of the Apotex eye drop recall:
  • The recalled eye drops are brimonidine tartrate ophthalmic solution 0.15% and require a prescription.
  • Apotex eye drops are used to treat people with glaucoma and ocular hypertension.
  • The lots affected in the recall totaled six sold between April 05, 2022, to February 22, 2023.
  • There have been no reports of injuries relating to the recalled Apotex eye drops.

Apotex indicated in an email that the eye drops were manufactured in Canada and that it has not received any reports of injury related to them. It launched the recall after finding cracks in “a handful of bottle caps.”

Were My Apotex Eye Drops Recalled?

To determine if your Apotex Eye Drops were from one of the six lots recalled, look at the NDC numbers printed on the carton and label of the product. Find the lot number and expiry date on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode. This FDA chart identifies the relevant NDC numbers:

Product Strength Pack Size NDC # UPC Code
on Carton		 UPC Code
on Bottle		 Lot # Expiry Date
Brimonidine Tartrate Ophthalmic Solution 0.15% 5 mL 60505-0564-1 360505056415 (01)0(03)
60505056415		 TJ9848 02/2024
TJ9849
TK0258 04/2024
TK5341
10 mL 60505-0564-2 360505056422 (01)0(03)
60505056422		 TK0261
15 mL 60505-0564-3 360505056439 (01)0(03)
60505056439		 TK0262

The lots were distributed nationwide in the U.S. between April 5, 2022, and February 22, 2023. If you have questions about this recall or have received one of the identified lots, contact your pharmacy or the healthcare provider that gave you the prescription.

What Should I Do If My Eye Drops Were Recalled?

If your eye drops were part of the recall, consult your doctor for an alternate prescription. If you have used the recalled eye drops and have experienced any unusual side effects or complications from the drops, let your doctor know right away.

Authorities have directed all wholesalers and pharmacies to quarantine all recalled lots immediately. You should no longer be in danger of buying an impacted product.

Other actions you can take if you’ve purchased or received eye drops that are part of the recall:
  • Report injuries to the FDA’s MedWatch at 1-800-332-1088 or www.fda.gov/medwatch/report.htm
  • Contact Apotex Corp. with questions at 1-800-706-5575 or UScustomerservice@Apotex.com
  • Contact Inmar Rx Solutions for a recall packet at 1-855-275-1273 or clsnetlink.com

The Apotex eye drops recall isn’t related to other eye drop recalls that you may have seen in the news recently. Other eye drops recall cases, including Ezricare and Delsam artificial tears, relate to serious injuries, including potential bacterial contamination, that have led to FDA investigations and subsequent lawsuits.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: October 4, 2023
Written By
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Mark C. Howell Jr., Ph.D. Medical and Health Sciences Expert Contributor Howell’s team works to enhance the understanding of disease burden and long-term symptom control in patients with atopic dermatitis. He works with academics and key opinion leaders to develop optimal publications. 
Consumer Notice editor Amy Edel
Edited By Amy Edel Editor

4 Cited Research Articles

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  1. AP News. (2023, March 7). FDA: Two more eyedrop brands recalled due to risks. Retrieved from https://apnews.com/article/eyedrops-recall-fda-infection-warning-bbc9ecb53c41c2370e86aa960cd3bfdf
  2. Jackson, K. (2023, March 6). Recall of brimonidine tartrate ophthalmic solution voluntarily issued by Apotex Corp. Retrieved from https://www.optometrytimes.com/view/recall-of-brimonidine-tartrate-ophthalmic-solution-voluntarily-issued-by-apotex-corp-
  3. U.S. Food & Drug Administration. (2023, March 2). Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due
  4. Cantor, L.B. (2006, December). Brimonidine in the treatment of glaucoma and ocular hypertension. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936355/