A Wave of Eye Drop Recalls: Protecting Your Vision
Recent years have seen an unprecedented number of recalls for over-the-counter (OTC) eye drops, raising significant public health concerns. The U.S. Food and Drug Administration (FDA), in collaboration with the Centers for Disease Control and Prevention (CDC), has issued warnings and facilitated recalls for numerous products due to risks of bacterial contamination and lack of sterility assurance [1.3.2, 1.4.1]. These issues have been linked to severe eye infections, vision loss, and even death, making consumer vigilance more important than ever [1.4.2, 1.7.4].
A major catalyst for this heightened scrutiny was a multistate outbreak of a rare, extensively drug-resistant strain of Pseudomonas aeruginosa [1.4.1, 1.7.1]. This dangerous bacterium was linked to artificial tears products manufactured by Global Pharma Healthcare in India and sold under brand names like EzriCare and Delsam Pharma [1.4.2, 1.4.3]. The outbreak resulted in dozens of infections, hospitalizations, cases of permanent vision loss, and several fatalities [1.7.4, 1.7.7]. Investigations by the FDA revealed unsanitary conditions and violations of Current Good Manufacturing Practices (cGMP) at the production facilities, such as a lack of proper sterility testing [1.4.2, 1.7.1, 1.7.7].
This prompted a broader crackdown. In late 2023 and continuing into 2024 and 2025, the FDA warned consumers not to purchase or use dozens of OTC eye drop products sold by major retailers like CVS, Rite Aid, Target, and Walmart [1.3.2, 1.3.7]. These subsequent recalls often stemmed from potential contamination risks found during facility inspections, even without direct reports of infection [1.4.5]. For example, in May 2025, distributor AvKare recalled over 75,000 cases of various eye drops due to cGMP deviations at the manufacturing plant, BRS Analytical Service, LLC [1.2.1, 1.2.3]. Another notable recall in late 2024 involved a specific lot of Systane Ultra PF due to fungal contamination [1.2.4, 1.2.6].
Comprehensive List of Recently Recalled Eye Drop Brands
Consumers should be aware of the numerous brands and products pulled from shelves. While this list is extensive, it is crucial to always check the FDA's official recall database for the most current information. Key recalls have included:
- EzriCare Artificial Tears & Delsam Pharma Artificial Tears/Ointment: Recalled in early 2023 due to contamination with Pseudomonas aeruginosa [1.4.1, 1.4.2].
- Various Store Brands (CVS, Target, Rite Aid, Walmart, etc.): Multiple lubricant eye drops, gel drops, and allergy relief drops were recalled starting in late 2023 due to manufacturing issues at a Kilitch Healthcare India Limited facility [1.3.4, 1.3.7].
- AvKare Products: In May 2025, five different prescription-grade ophthalmic products were recalled due to quality control failures at the manufacturing site [1.2.1, 1.2.2]. These included Artificial Tears Ophthalmic Solution and Carboxymethylcellulose Sodium Ophthalmic Gel, among others [1.2.3].
- Systane Lubricant Eye Drops Ultra PF (Single Lot): Recalled in December 2024 due to potential fungal contamination in lot 10101 [1.2.4, 1.2.8].
- Apotex Brimonidine Tartrate Ophthalmic Solution: A prescription glaucoma drop recalled due to concerns about cracked caps that could compromise sterility [1.4.5].
- Pharmedica Purely Soothing 15% MSM Drops: Recalled because the products were not sterile [1.4.5].
Comparison of Major Recalled Product Categories
| Product Category | Primary Reason for Recall | Associated Risks | Key Brands Involved |
|---|---|---|---|
| Artificial Tears (Lubricant) | Bacterial Contamination (P. aeruginosa) | Severe eye infections, bloodstream infections, vision loss, death [1.4.2, 1.7.4] | EzriCare, Delsam Pharma [1.4.3] |
| Store-Brand Eye Drops | Unsanitary Manufacturing Conditions | Potential for eye infection and blindness [1.3.2] | CVS Health, Target Up&Up, Rite Aid, Leader, Rugby [1.3.7] |
| Prescription-Grade Ophthalmic Solutions | cGMP Deviations / Lack of Sterility Assurance | Potential for non-sterile product, leading to infection risk [1.2.1, 1.2.2] | AvKare [1.2.3] |
| Specialty PF Vials | Fungal Contamination | Potential for serious eye infection [1.2.4, 1.2.8] | Systane Ultra PF (one lot) [1.2.6] |
Symptoms and What to Do
Using a contaminated eye drop can lead to serious eye infections. Seek immediate medical care if you experience any of the following symptoms after using eye drops [1.5.2, 1.5.5]:
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- Feeling like something is in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision
If you discover you own a recalled product, the FDA and CDC advise you to stop using it immediately [1.4.1]. Do not discard it in a way that others might find and use it. The safest course of action is to return it to the place of purchase or follow the recall instructions provided by the manufacturer [1.2.4]. You can report any adverse reactions to the FDA's MedWatch program [1.4.1].
How to Check if Your Eye Drops Are Safe
- Visit the FDA Website: The most reliable way to check for recalls is to search the FDA's official recall database [1.6.1, 1.6.4]. You can search for the product name or the general term "eye drops." [1.6.2].
- Check NDC and Lot Numbers: Recall notices will include specific identifiers like the National Drug Code (NDC) and lot numbers printed on the packaging [1.2.5, 1.4.2]. Compare these numbers with those on your product.
- Consult Your Pharmacist or Doctor: If you are unsure about a product, your healthcare provider or pharmacist can offer guidance and recommend safe alternatives [1.6.5].
Conclusion: A New Standard of Caution
The widespread recalls of over-the-counter eye drops have fundamentally changed the landscape of consumer trust and regulatory oversight. The severe outcomes linked to contaminated products, particularly from the Pseudomonas aeruginosa outbreak, serve as a stark reminder that sterility is non-negotiable for ophthalmic products [1.7.1, 1.7.4]. While the FDA is increasing inspections and proposing stronger regulations, the responsibility also falls on consumers to be vigilant [1.6.1, 1.7.1]. Always check for recalls, inspect packaging, and consult healthcare professionals to ensure the products you use to soothe your eyes do not cause irreparable harm. For the most up-to-date safety information, refer to the official FDA Drug Recalls page [1.6.6].
