• Published: May 14 2025 12:08 PM
  • Last Updated: May 29 2025 11:50 AM

Millions of bottles of AvKARE-distributed eye drops are recalled due to manufacturing flaws. The FDA classified the recall as Class II, urging consumers to immediately stop use and seek refunds.


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Urgent: Millions of Eye Drops Pulled From Shelves in Major Recall

If you rely on over-the-counter eye drops for daily comfort, you'll want to check your medicine cabinet ASAP. Millions of bottles of popular artificial tears and lubricating eye solutions are being yanked from store shelves across the country. The reason? A recent Food and Drug Administration (FDA) inspection uncovered some pretty alarming manufacturing issues that could put your eye health at risk.

The distributor, AvKARE, didn't waste time in announcing this voluntary recall after BRS Analytical Service, LLC failed an FDA audit. It turns out there were significant problems with their manufacturing practices—basically, the FDA couldn't guarantee these products were properly sterile. And when it comes to something you're putting directly in your eyes, sterility isn't exactly optional.

So What Exactly Is Being Recalled?

We're talking about five different eye care products that were shipped between May 2023 and April 2025. That's a long window, which means you might still have these drops sitting in your bathroom right now. While no specific illnesses have been reported yet from these particular products (thank goodness), the FDA isn't taking any chances. They've classified this as a Class II recall, which is FDA-speak for "there's a reasonable chance these products could cause serious health problems or even death." Not exactly comforting, right?

Here's the full list of what you need to look out for:

  • Artificial Tears Ophthalmic Solution (NDC# 50268-043-15) – A whopping 13,872 cases recalled
  • Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15) – 1,610 cases recalled
  • Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC# 50268-068-15) – A massive 32,876 cases recalled
  • Lubricant Eye Drops Solution (with Polyethylene Glycol 400/Propylene Glycol) (NDC# 50268-126-15) – 13,104 cases recalled
  • Polyvinyl Alcohol Ophthalmic Solution 1.4% (NDC# 50268-678-15) – 14,333 cases recalled

All told, we're looking at more than 1.8 million cartons affected. That's a lot of eye drops!

Product Name NDC Number Cases Recalled
Artificial Tears Ophthalmic Solution 50268-043-15 13,872
Carboxymethylcellulose Sodium Ophthalmic Gel 1% 50268-066-15 1,610
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% 50268-068-15 32,876
Lubricant Eye Drops Solution 50268-126-15 13,104
Polyvinyl Alcohol Ophthalmic Solution 1.4% 50268-678-15 14,333

Found Some in Your Medicine Cabinet? Here's What to Do

First things first: stop using them immediately. I know it's tempting to think, "Well, they've been fine so far..." but when it comes to your eyes, why take the risk? Imagine waking up with an eye infection because of contaminated drops—definitely not worth it.

The good news? AvKARE is offering full refunds, including shipping costs. Getting your money back is pretty straightforward: just fill out the recall form on AvKARE's website and send it via fax or email. They'll then guide you through returning the product.

Haven't experienced any issues yet? That's great, but don't let it give you a false sense of security. Eye infections can develop quickly, and the consequences can be serious.

This Isn't the First Time—And That's Concerning

If you're feeling a bit of déjà vu, you're not wrong. This is just the latest in a string of eye drop recalls this year. Some previous recalls were linked to serious infections, and in the worst cases, even deaths. It's a sobering reminder of why these manufacturing standards exist in the first place.

Let's face it—most of us don't think twice about the safety of our eye drops. We assume they're held to the highest standards, as they should be. But these recent recalls are forcing many of us to take a closer look at what we're putting in our eyes.

The Bigger Picture

The FDA has been ramping up its vigilance lately, and for good reason. Eye drops might seem harmless, but they bypass many of the body's natural defenses, delivering substances directly to one of our most sensitive organs. When something goes wrong, it can go wrong quickly—and with devastating consequences.

Think about it: you wouldn't eat food from a restaurant with questionable hygiene practices, right? Your eyes deserve the same level of caution, if not more.

What Now?

This massive recall serves as a wake-up call for both manufacturers and consumers. For companies, it highlights the critical importance of maintaining strict quality controls. For us as consumers, it's a reminder to stay informed about the products we use daily.

Don't have these specific products but still feeling uneasy about your eye drops? Check the FDA's recall website to make sure your brand isn't on any other recall lists. And if you're experiencing any eye irritation, redness, or discomfort after using eye drops—even ones not on recall lists—don't hesitate to call your doctor.

Your vision is precious. Treat it that way. When it comes to your eyes, being a little paranoid is probably a good thing. Better safe than sorry, especially when your sight is at stake.

FAQ

The recall affects millions of AvKARE-distributed eye drop bottles. Check your specific product against the FDA recall list to see if it's affected. This Class II recall is due to manufacturing flaws causing contamination.

The FDA issued a Class II recall due to manufacturing defects in AvKARE eye drops. The contamination risks severe eye health problems. Stop using the affected products immediately.

Check the FDA website for the complete list of recalled lots and product numbers. Compare your bottles against the list to see if they are included in the recall.

Immediately stop using the recalled AvKARE eye drops. Contact AvKARE or the retailer where you purchased them for a refund. This urgent recall is for consumer safety and eye health.

Yes, the FDA classified this as a Class II recall, indicating a potential for serious health consequences. Contaminated eye drops pose significant risks to your eye health.

Using contaminated eye drops can lead to serious eye infections and other vision-threatening complications. The manufacturing defect causing this contamination necessitates immediate action.

Check the FDA website for official updates and details about the recall, including a list of affected lots. The FDA recall notice provides detailed information on consumer safety.

Contact AvKARE directly or the retailer where you purchased the eye drops to initiate the refund process. The company should provide details on how to obtain your refund.

This is a Class II recall issued by the FDA. This means the use of the contaminated eye drops may cause temporary or medically reversible adverse health consequences.

If you've experienced any eye problems after using the recalled eye drops, seek immediate medical attention from an ophthalmologist or your doctor. Document your symptoms.

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