2023–2025 Eye Drop Recall: What You Need to Know
Millions of Americans rely on over-the-counter (OTC) eye drops to soothe dry, itchy, or irritated eyes. However, a recent nationwide recall has raised alarms about product safety. Over 75,000 cases of ophthalmic solutions were voluntarily recalled by BRS Analytical Service, a pharmaceutical testing lab, following an FDA audit that uncovered critical manufacturing violations. This article breaks down everything you need to know about the recall, which products are affected, and how to protect your eye health.
Why Are These Eye Drops Being Recalled?
The recall stems from Current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection of BRS Analytical Service. cGMP regulations ensure pharmaceutical products are produced safely and meet quality standards. According to AvKare, the manufacturer behind the recall, these violations could compromise product sterility, posing potential risks to users.
Key issues include:
- Lack of sterility assurance : Contaminated eye drops can lead to severe eye infections, vision damage, or even blindness.
- Poor quality control : Deviations in manufacturing processes may result in inconsistent product efficacy.
AvKare’s official statement warns: “cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
Which Products Are Affected?
The recall covers five ophthalmic solutions distributed nationwide between May 26, 2023, and April 21, 2025 . If you own any of these products, stop using them immediately:
- 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)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
What Should You Do If You Have These Products?
- Stop using the product immediately.
- Return for a full refund:
- Fill out AvKare’s Recall Form and email it to the company.
- Receive a Return Authorization Form and ship products to:
R&S Northeast LLC, 8407 Austin Tracy Rd, Fountain Run, KY 42133 - AvKare will cover shipping costs and issue full credit.
Expert-Recommended Alternatives for Dry Eyes
Dry eye sufferers have safer alternatives to manage symptoms while avoiding recalled products. Dr. Yuna Rapoport, a board-certified ophthalmologist at Manhattan Eye, recommends the following:
1. Warm Compresses
Apply a warm compress for 30 seconds daily to treat aqueous dry eye or blepharitis. Try:
- Rest Self Heating Warm Compress : 30 self-heating pads (4.5-star Amazon rating).
- Bruder Moist Heat Eye Compress : Reusable, microwaveable mask (28K+ reviews).
2. Humidifiers
Add moisture to your environment with a Levoit Humidifier (2.5L capacity, BPA-free). Ideal for allergy sufferers.
3. Eyelid Cleansers
- Ocusoft Lid Wipes : Fragrance-free pads to remove irritants like pollen and makeup.
- Daily Practice Purifying Foam Cleanser : Contains aloe vera and saccharide isomerate for hydration.
Why Trust These Alternatives?
Dr. Rapoport emphasizes that non-invasive treatments like warm compresses and lid hygiene address root causes of dry eye, such as blocked meibomian glands. Humidifiers combat environmental triggers, while cleansers reduce bacterial buildup linked to blepharitis.
Frequently Asked Questions (FAQs)
Q: Is this recall nationwide?
A: Yes, the recall affects products distributed across the U.S.
Q: Can I use FSA funds for alternatives?
A: Yes! Products like warm compresses and humidifiers qualify for FSA/HSA reimbursement.
Q: What if I’ve already used a recalled product?
A: Monitor for symptoms like redness, pain, or vision changes. Consult an ophthalmologist immediately if issues arise.
Stay Informed: Follow the Latest Recall Updates
This recall highlights the importance of staying vigilant about product safety. Always check the FDA’s recall database or subscribe to alerts from reputable health organizations.
Conclusion
The 2023–2025 eye drop recall underscores the need for caution when using OTC medications. By identifying affected products and opting for expert-approved alternatives, you can safeguard your eye health. Share this guide to help others stay informed!
