Eye Care Product Recalls in 2025: What You Need to Know to Stay Safe

 

Eye care products, such as eye drops and ointments, are essential for millions of Americans seeking relief from dry eyes, allergies, or other eye-related discomforts. However, recent recalls in 2025 have raised concerns about the safety of over-the-counter (OTC) eye care products, particularly due to manufacturing issues that could lead to infections or vision loss. This article provides a comprehensive, SEO-optimized guide to the latest eye care product recalls in the United States, focusing on the most recent data, affected products, and actionable steps to protect your eye health.

Why Eye Care Product Recalls Matter

Eye care products, especially eye drops and ointments, are applied directly to the eyes, bypassing many of the body’s natural defenses. This makes sterility and quality critical to prevent infections, which can range from mild irritation to severe conditions like vision loss or blindness. The U.S. Food and Drug Administration (FDA) has been vigilant in monitoring manufacturing practices, and recent audits have uncovered violations that prompted significant recalls in 2025.

These recalls are part of a broader trend of increased scrutiny following a series of eye drop recalls in 2023 and 2024, some of which were linked to bacterial contamination and serious health outcomes, including vision loss and deaths. In 2025, the focus remains on ensuring consumer safety, particularly as allergy seasons intensify and demand for eye drops rises.

The Latest Eye Care Product Recall: AvKARE and BRS Analytical Service (May 2025)

Overview of the Recall

On April 23, 2025, BRS Analytical Service, LLC, in collaboration with distributor AvKARE, announced a voluntary nationwide recall of approximately 1.8 million cartons of five ophthalmic solutions, including eye drops and artificial tears. This recall, reported on May 6, 2025, by the FDA, was triggered by an FDA audit that identified violations of current Good Manufacturing Practices (cGMP). These violations raised concerns about the products’ sterility and quality, potentially posing risks to consumers.

The recalled products, distributed between May 26, 2023, and April 21, 2025, include:

• Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)

• Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)

• Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)

• Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC# 50268-067-15)

• Hypromellose Ophthalmic Solution (NDC# 50268-042-15)

These products were sold nationwide through retailers, pharmacies, and online platforms. The FDA classified this recall as Class II on May 6, 2025, indicating that the products may cause temporary or medically reversible adverse health effects, with a remote probability of serious consequences.

Health Risks and Consumer Actions

While no adverse events have been reported as of May 12, 2025, the lack of sterility assurance is a significant concern. Using contaminated eye drops can lead to infections, which may cause symptoms like redness, discharge, pain, or vision changes. In severe cases, infections can progress to vision-threatening conditions.

Consumers are urged to:

• Stop using the recalled products immediately.

• Check product packaging for the listed National Drug Codes (NDCs) and lot numbers, available on the FDA’s recall notice.

• Return the products to AvKARE for a full refund, including shipping costs, by completing the “Quantity to Return” section of the recall notice and emailing it to customerservice@avkare.com or faxing it to 931-292-6229.

• Report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.

AvKARE has expressed regret for the inconvenience and is working to address the manufacturing issues. For questions, consumers can contact AvKARE at customerservice@avkare.com.

Context: A Pattern of Eye Care Product Recalls

The AvKARE recall is the latest in a series of eye care product recalls that have heightened public awareness since 2023. Here’s a brief overview of notable recalls that set the stage for 2025:

2023: Kilitch Healthcare India Limited Recall

In October and November 2023, Kilitch Healthcare India Limited recalled 28 OTC eye drop products sold by major retailers like CVS, Rite Aid, Target, and Walmart. The FDA identified unsanitary conditions and bacterial contamination in the manufacturing facility, posing a risk of eye infections that could lead to partial vision loss or blindness. Products included lubricating drops and gels under brands like Equate, Leader, and Rugby. No adverse events were reported, but the recall affected millions of units.

2024: Brassica Pharma Eye Ointment Recall

In February 2024, Brassica Pharma recalled four eye ointments sold under brands like Equate, CVS Health, and AACE Pharmaceuticals due to potential sterility issues at the manufacturing facility. The recalled products, packaged in 3.5-gram tubes, were distributed at Walmart and CVS. No health problems were reported, but the recall underscored the importance of sterile manufacturing for eye care products.

2024: Copycat Eye Drops Warning

In January 2024, the FDA warned consumers against using unapproved eye drops marketed as South Moon, Rebright, and FivFivGo, which mimicked Bausch + Lomb’s Lumify brand. These products, sold online, claimed to treat conditions like glaucoma but posed infection risks due to lack of FDA approval.

These earlier recalls highlight a recurring issue: manufacturing violations and contamination risks in OTC eye care products. The 2025 AvKARE recall continues this trend, driven by increased FDA oversight following the COVID-19 pandemic, when in-person inspections were limited.

Why Are Eye Care Products Vulnerable?

Eye care products are particularly susceptible to contamination because they must be sterile to be safe. Unlike oral or topical medications, eye drops and ointments are applied directly to the eye, where bacteria or impurities can cause rapid harm. Manufacturing facilities must adhere to strict cGMP standards, but violations—such as unsanitary conditions or inadequate quality controls—can compromise product safety.

Experts note that OTC eye drops face less regulatory scrutiny than prescription products, which are subject to rigorous pre-market approval. This difference explains why all recent recalls have involved OTC products, while prescription eye drops, such as those for glaucoma, remain unaffected.

Additionally, the rise in “copycat” eye drops—unapproved products that mimic trusted brands—has added to the problem. These products often make misleading health claims and are sold online, evading traditional regulatory checks.

How to Protect Your Eye Health

With recalls becoming more frequent, consumers can take proactive steps to ensure their eye care products are safe:

1. Check for Recalls: Regularly visit the FDA’s recall page (www.fda.gov/safety/recalls) or sign up for email alerts to stay updated on recalled products. Compare product names and NDCs on your eye drops or ointments to the recall lists.

2. Inspect Products: Before using eye drops or ointments, check the expiration date and ensure the packaging is intact. Avoid using products if the solution appears cloudy or discolored.

3. Choose Preservative-Free Options: Opt for preservative-free eye drops in single-use vials, which are less prone to contamination. These are recommended by eye care professionals for frequent use or sensitive eyes.

4. Consult an Eye Care Professional: If you’re unsure about the safety of your eye drops, consult an optometrist or ophthalmologist. They can recommend safe alternatives and guide you on proper use.

5. Monitor for Symptoms: If you’ve used a recalled product and experience symptoms like redness, pain, discharge, or vision changes, seek medical care immediately. Early treatment can prevent complications.

6. Dispose of Recalled Products Safely: Follow FDA guidelines for disposing of recalled eye care products, which may involve returning them to a drug take-back site or following specific disposal instructions.

The Role of the FDA and Industry Response

The FDA’s increased oversight of eye care product manufacturing is a response to past incidents, including a 2023 outbreak linked to contaminated eye drops that caused 14 cases of vision loss and four deaths. By conducting regular audits and environmental sampling, the FDA aims to prevent similar tragedies. The agency collaborates with manufacturers to issue voluntary recalls and ensure that retailers like Walmart and CVS remove affected products from shelves.

Retailers have been quick to respond. For example, Walmart removed the recalled Equate Hydration PF Lubricant Eye Drops in 2023 and is likely doing the same for the 2025 AvKARE recall. Amazon also removed unapproved eye drops from its platform in 2023 after FDA warnings.

Looking Ahead 

The 2025 AvKARE recall serves as a reminder that even trusted eye care products can pose risks if manufacturing standards falter. As allergy seasons worsen due to climate change, demand for eye drops is expected to rise, making vigilance more important than ever.

By staying informed, checking product safety, and consulting eye care professionals, you can protect your vision and avoid the risks associated with recalled products. For the latest updates, visit the FDA’s website or contact your healthcare provider if you have concerns about specific eye drops or ointments.