Eyedrop recalls are initiated to safeguard public health and ensure the safety of over-the-counter and prescription medications. These recalls occur when products fail to meet established quality and safety standards, posing potential risks to users. Their swift removal from the market prevents adverse health outcomes and maintains product integrity.
Currently Recalled Eyedrops
Recent recalls have impacted several eyedrop products, stemming from various manufacturing and contamination concerns. One significant recall involved EzriCare Artificial Tears and Delsam Pharma Artificial Tears, manufactured by Global Pharma Healthcare. These products were recalled in February 2023 due to potential bacterial contamination. Global Pharma Healthcare also recalled Delsam Pharma Artificial Eye Ointment in February 2023, citing possible microbial contamination and issues with packaging integrity, such as leaking tubes.
Another product, Purely Soothing 15% MSM Drops from Pharmedica USA LLC, was subject to a worldwide recall in March 2023 due to non-sterility. Additionally, Apotex Corp. issued a voluntary recall for six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%, in March 2023, because cracks developed in some bottle caps, potentially compromising the product’s sterility.
More recently, in October 2023, the FDA warned consumers about 26 over-the-counter eyedrop products from various brands, including CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, and Velocity Pharma, due to potential contamination. These products were manufactured by Kilitch Healthcare India Limited. In February 2024, lubricant eye ointments from Brassica Pharma Pvt. Ltd., sold under brands like Equate, CVS Health, and AACE Pharmaceuticals, were recalled due to sterility concerns at the manufacturing facility. The most recent recall in May 2025 involved ophthalmic solutions from BRS Analytical Service, LLC, distributed by AvKare, due to “unacceptable quality” and a lack of assurance of sterility.
Understanding Recall Reasons
Eyedrop recalls are typically initiated due to deviations from manufacturing standards that can compromise product safety. A common reason for these recalls is microbial contamination, particularly with bacteria or fungi. For instance, the EzriCare and Delsam Pharma recalls were linked to contamination with Pseudomonas aeruginosa, a drug-resistant bacterium.
Other recalls, such as that for Purely Soothing 15% MSM Drops, were due to non-sterility, meaning the manufacturing process failed to prevent harmful microorganisms. Manufacturing violations, including inadequate microbial testing, formulation issues, and improper controls for tamper-evident packaging, were cited as reasons for the EzriCare and Delsam Pharma recalls. Issues with product packaging, such as cracks in bottle caps, can also compromise sterility and lead to recalls.
Potential Health Risks and User Actions
Using recalled eyedrops can lead to severe eye infections. These infections can manifest as eye pain, redness, discharge, blurry vision, and increased sensitivity to light. In some cases, such infections can progress to permanent vision loss, and in severe instances, may even necessitate surgical removal of the eye. There have also been reports of systemic infections, including bloodstream infections, and even death linked to contaminated eyedrops.
If you possess or have used a recalled eyedrop product, discontinue use immediately. Properly dispose of the product to prevent accidental use by others. If you experience any symptoms of an eye infection or have concerns about your eye health after using a recalled product, contact a healthcare provider promptly.
How to Stay Updated on Recalls
Staying informed about product recalls is important for consumer safety. The U.S. Food and Drug Administration (FDA) announces drug recalls, including those for eyedrops. Their website is a reliable source for official recall announcements and detailed information. The FDA posts company announcements regarding recalls, market withdrawals, and safety alerts.
Regularly check the FDA’s website for the most current list of recalled products. Consumers can also subscribe to recall alerts or news feeds from official sources to receive timely notifications. If you have questions about a specific recall, contact the manufacturer or distributor directly using the contact information provided in the recall notice.