More than 3 million eye drop bottles have been recalled from CVS, Walgreens and other national retailers. How to check if yours are safe.

U.S. health regulators are warning Americans to check their eye drops after 3.1 million bottles of the product sold in pharmacies nationwide were voluntarily recalled due to concerns they may not be sterile.

All of the affected eye drops were made by K.C. Pharmaceuticals, and include the company’s Artificial Tears, Advanced Relief, Dry Eye Relief and Redness Lubricant drops.

The recall doesn’t necessarily mean these drops are contaminated, but that the manufacturer can’t guarantee the products are free of infection-causing bacteria or fungi. K.C. Pharmaceuticals has voluntarily recalled some of its eye drops, but the Food and Drug Administration is warning consumers to check their medicine cabinets and throw out any potentially hazardous products.

Which products have been recalled?

Eight different eye drop products made by K.C. Pharmaceuticals have been recalled. All are generic products, meaning they are sold under the store brand names, including Kroger, H-E-B, CVS, Rite Aid and Walgreens. The types of products that were recalled are:

2. Advanced Relief Eye Drops

4. Ultra Lubricating Eye Drops

5. Sterile Eye Drops (original formula)

6. Sterile Eye Drops Redness Lubricant

7. Artificial Tears Sterile Lubricant Eye Drops

8. Sterile Eye Drops Soothing Tears

The recalled products have expiration dates ranging from April 30 to July 31, 2026. Many of them can be identified by their Universal Product Code or National Drug Code numbers. Here’s a full list of affected products.

What to do if you bought recalled eye drops 

The FDA’s recall did not include instructions for consumers, but generally speaking, it’s best to throw out any affected products. You may also be able to return recalled products to where you purchased them for a refund, according to the FDA.

K.C. Pharmaceuticals initially recalled its eye drops on March 31, so the products have likely been pulled from store shelves by now. But if you’re shopping for drops, it’s wise to cross-check the labels against the full product recall list, especially if you’re considering buying the store brand.

Eye drops that are not sterile can pose serious risks

The good news is that no contamination has actually been detected thus far, and no one has reported an infection resulting from the use of any of K.C. Pharmaceuticals’ eye drops.

K.C. Pharmaceuticals’ eye drops were recalled primarily due to a “lack of assurance of sterility,” the FDA said. That means the company cannot guarantee its products weren’t contaminated during production or packaging. If the products aren’t sterile, they could contain bacteria, fungi, spores or viruses that can pose serious risks.

“Whenever we talk about using eye drops for the ocular system, it’s really important that there’s no bacterial contamination because that can cause significant and sight-threatening infections,” Dr. Nicole Bajic, a Cleveland Clinic ophthalmologist, told Yahoo.

Beyond pain and irritation, these infections can cause yellow or green discharge and blurred vision. In 2023, 81 people developed rare, antibiotic-resistant infections with the bacteria Pseudomonas aeruginosa after using contaminated eye drops. Four of those people died, and four had to have an eye surgically removed. Another 14 patients experienced vision loss.

Bajic noted that it can be difficult for patients to determine if their symptoms are run-of-the-mill eye dryness or irritation, or if they have an infection from contaminated eye drops — or another source. But if you have worsening eye pain, vision, irritation or light sensitivity that isn’t improving with artificial tears or warm compresses, you should see a health care provider immediately, she said.

How regulators keep eye drops safe — and why recalls happen

FDA regulators require a rigorous process to ensure that products that need to be sterile are made safely. Manufacturers have to make their products in a sterile environment, go through a process of removing any potential bacteria or other microorganisms from their products, test them, keep them in a holding period to see if they grow any harmful microbes and meticulously seal them.

If at any point in this complex chain of events something goes wrong — whether the production plant finds contamination in its facility, or plastic seals are defective — then a manufacturer can’t guarantee the product is sterile and is obligated to recall it. If it doesn’t, the FDA will request or mandate that the company issue a recall.

Sterility issues are a more common problem in over-the-counter eye drops than prescription ones, but thanks to these strict regulations, it’s extremely rare for any eye products to be recalled. When they are, it’s to be taken seriously.

Tips for using eye drops safely

Eye drops can help alleviate symptoms such as dryness and irritation, but only if you use the right kind. Bajic said that her No. 1 priority when recommending products to her patients is that they make sure they’re getting true artificial tears rather than redness-reducing drops.

Artificial tears mimic your eye’s natural lubricants, while redness-relieving products use ingredients that only have a temporary cosmetic effect. And, because they reduce redness by constricting blood flow to your eyes, these drops create a “vicious cycle” that dries your eyes out more as you use them, Bajic said.

Additionally, the number of eye drop recalls has been growing in recent years. Bajic said that “the prevailing theme seems to be that generics make up the bulk of them. Historically, I’ve told patients … that I don’t feel strongly about choosing brand names for artificial tears, but seeing the pattern that’s emerged in these recalls, I feel more confident recommending brand-name products.”

Eye Drop Safety, a consumer safety organization, advises against using products that claim to be “natural” or “homeopathic” because the FDA doesn’t regulate them like it does other artificial tears, meaning they may not be safely produced or might contain unproven ingredients.