What is in the eye drops recall? Nearly 750,000 units of lubricant eye drops and eye ointment, including more than 500,000 Walgreens store brand units, are being pulled because they may not be sterile, according to the U.S. Food and Drug Administration. Sterling Pharmaceutical Services LLC of Dupo, Illinois, started the recall Aug. 20. The FDA classified it as Class II on Sept. 21.
What should you do? Check the product name, lot number and expiration date on any drops in your medicine cabinet against the FDA’s enforcement report. If yours match, stop using them and call your doctor.
Which products are in the eye drops recall?
The recall covers 747,844 units across nine products sold under six brand names. Walgreens alone accounts for about 67% of the total. Here are the products, ranked by the number of units pulled.
- Walgreens Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%, 0.5 fl oz bottles, 301,114 bottles
- Walgreens Lubricant Eye Drops twin packs, 199,600 packs
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops twin packs, 107,377 packs
- Reliable-1 Laboratories Lubricating Tears, 0.5 fl oz, 47,616 bottles
- Major LubriFresh P.M. Nighttime Ointment, 0.125 oz tubes, 34,368 tubes
- Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant, 0.5 fl oz, 19,284 bottles
- TRP The Relief Products Gentle Eyes Lubricant Eye Drops, 14,538 bottles
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops, 0.5 fl oz bottles, 12,864 units
- Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5%, 0.5 fl oz, 11,083 bottles
Why does the eye drops recall lead back to one Illinois factory?
Most coverage skips this part. Six brands, one manufacturer. Store brand drops are often made by contract manufacturers, so the name on the box rarely tells you who produced what is inside. In this case the maker is Sterling, which lists ophthalmic products among the specialty markets it serves, alongside prescription, over the counter, veterinary and homeopathic products.
FDA records show regulators have raised sterility concerns at this facility before. After a May 2021 inspection, the first observation investigators recorded was that the plant did not have established, written and followed procedures to keep microbes out of products labeled sterile. A February 2022 inspection opened with a finding that the aseptic process used to prevent contamination of sterile products had not been adequately validated. Months later, the FDA sent the company a warning letter dated Sept. 27, 2022, citing significant violations of current good manufacturing practice rules.
Those records do not prove the recalled batches are contaminated. The FDA describes the current problem as a lack of assurance that the products are sterile. The history still raises fair questions about how a facility flagged more than once kept producing drops for national shelves. Sterling did not respond to USA TODAY’s request for comment Oct. 2.
How serious is a Class II eye drops recall?
Class II means using the product may cause temporary or medically reversible health problems, and the chance of serious harm is remote. Sterility still matters a great deal for anything that goes in the eye. A separate outbreak tied to contaminated artificial tears made in India, which has no connection to this recall, showed the stakes. Investigators counted 81 patients across 18 states. Four died within 30 days, four had to have an eye removed and 14 more lost vision.
Who should watch this eye drops recall most closely?
The people most at risk are those who use lubricant drops daily, those healing from eye surgery and anyone with a weakened immune system. That carries weight in Black communities, where glaucoma and diabetes rates run higher and many families rely on the neighborhood drugstore for everyday eye care.
Watch for redness, pain, discharge or blurry vision, and contact a doctor if any of those show up. Questions about a specific bottle can go to the store where you bought it or to the FDA’s recall database.
