Litigation Guides

FDA Recall of Eye Drops

Recalls of several eye drop brands for non-sterility raise concerns about injuries or infection. In the case of one product, injuries and infections have already been reported, leading to serious or fatal health outcomes.

Medically Reviewed


Background of Eye Drop Recall

In February and early March 2023, the US Food and Drug Administration announced the voluntary recall of three ophthalmic products:

  • EzriCare Artificial Tears Lubricant Eye Drops, a GlobalPharma product
  • Brimonidine Tartrate Ophthalmic Solution (0.15%), an Apotex Corp. product
  • Purely Soothing 15% MSM Drops, a Pharmedica USA product

In an August 2023 update, the FDA added two additional types of eye drops to their warning list:

  • Dr. Berne’s MSM Drops 5% Solution
  • LightEyez MSM Eye Drops - Eye Repair1

In October 2023, the FDA expanded the list further to include over two dozen over-the-counter eye drop products.2 To date, only the EzriCare Artificial Tears have been linked to any injuries.

Person using eye drops

Which Eye Drop Products Were Recalled?

Global Pharma Healthcare EzriCare Artificial Tears Recall

The EzriCare Artificial Tears recall was issued after affected batches of the product tested positive for contamination with a drug-resistant strain of Pseudomonas aeruginosa, a bacterial pathogen.3

In its recall materials, the FDA focuses on violations of Global Pharma Healthcare’s current good manufacturing practice (CGMP) obligations:

  • Lack of appropriate microbial testing,
  • Formulation issues linked to the company distributing the product in multi-use bottles without adequate preservatives, and
  • Lack of tamper-evident packaging controls.

Cases of Pseudomonas aeruginosa infection related to the use of EzriCare Artificial Tears have been reported in fifteen states: California, Colorado, Connecticut, Florida, Illinois, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin.3

In 2023, over 55 reports of injuries linked to the use of EzriCare Artificial Tears were reported to the FDA.4 Most reports described eye infections, but some reported total vision loss, surgeries required to remove an eye, and death by systemic infection.3

Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%); Alphagan P

Alphagan P is the brand name of Apotex Corp’s Brimonidine Tartrate Ophthalmic Solution (0.15%). Apotex received FDA approval to sell the solution under its brand name Alphagen P in January 2022 to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.5

In March 2023, Apotex Corp issued a voluntary recall of six lots of Alphagan P due to potential lack of sterility after bottle caps cracked. No injuries were reported.6

Pharmedica USA LLC Purely Soothing 15% MSM Drops Recall

Pharmedica USA LLC Purely Soothing 15% MSM drops were recalled for “non-sterility.” The recall was issued worldwide. To date, no injuries or infections have been reported.7



EzriCare Artificial Tears

Some containers of EzriCare artificial tears have been reported to be contaminated with Pseudomonas aeruginosa. The strain of Pseudomonas aeruginosa (VIM-GES-CRPA) is a drug-resistant strain, never reported in the US before this outbreak.

EzriCare Artificial Tears have been linked to several serious infections, three deaths, eight cases of vision loss, and four cases requiring surgical removal of the entire eyeball.

The product has been voluntarily recalled by its maker, Global Pharma Healthcare.

Alphagan P

Cracks on the bottle cap led to a voluntary recall of six lots of Alphagan P. No injuries were reported.

Purely Soothing

“Non-sterility” led to a recall of several lots of Pharmedica USA LLC Purely Soothing 15% MSM Drops. No injuries were reported.

background image

Working On An Eye Drop Case?

We’re helping attorneys access the latest legal research, medical record reviews, physician consultations, and world-class experts.


Strength of Available Evidence

EzriCare: HIGH. Available evidence strongly supports the inference that EzriCare Artificial Tears were contaminated with a strain of bacteria not previously identified in the United States, and that infection with this bacterial strain led to eye infections, systemic infections, vision loss, the need for surgery, and/or death in various patients.

Alphagan P and Purely Soothing: LOW. As no injuries or infections have yet been linked to these recalls, available evidence does not support the inference that the recalled products have in fact caused injuries.


Works Cited


Howard L. “FDA warns people not to use 2 types of eye drops due to contamination.” Eye Health and Vision Science March 2023 (updated August 2023). UC Davis Health.


US Food & Drug Administration. “FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection.”


Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears. Centers for Disease Control and Prevention. Healthcare-Associated Infections (HAIs) Web site. Published 2023. Updated 03/21/2023. Accessed 04/03, 2023.


Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination. U.S. Food and Drug Administration. Recalls, Market Withdrawals, & Safety Alerts Web site. Published 2023. Updated 02/02/2023. Accessed 04/03, 2023.


2022 First Generic Drug Approvals. U.S. Food and Drug Administration Drug and Biologic Approval and IND Activity Reports Web site. Published 2023. Updated 03/03/2023. Accessed 04/03, 2023.


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. U.S. Food and Drug Administration. Recalls, Market Withdrawals, & Safety Alerts Web site. Published 2023. Updated 03/02/2023. Accessed 04/03, 2023.


Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility. U.S. Food and Drug Administration. Recalls, Market © 2021 Expert Institute | | 888.858.9511 Prepared by Expert Institute for at The Law Office of EI. Redistribution is STRICTLY PROHIBITED. FDA Recall of Eye Drops | 10 Withdrawals, & Safety Alerts Web site. Updated 03/03/2023. Accessed 04/03, 2023.

About the authors

Wendy Ketner, M.D.

Wendy Ketner, M.D.

Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.

Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.

Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.

background image

Subscribe to our newsletter

Join our newsletter to stay up to date on legal news, insights and product updates from Expert Institute.

Case Type*
I need help with...*