More than 4.8 million cartons of over-the-counter eye drops are being recalled nationwide because the maker cannot assure they are sterile, according to the FDA's recall record. The recall is voluntary, started by the company on Sept. 11 and sent to customers by email, and the record lists it as ongoing with distribution across the United States. The FDA classified it on Oct. 5. WECU News reviewed the record's product table and event details. The brand count comes from The Healthy, which reported the recall.
4.8 Million Eye Drop Cartons Recalled Over Sterility Concerns
The recall covers 27 brands, including store labels. The maker also recalled 3.1 million bottles in March and drew an FDA warning letter in August.
By Lynn Matthews - October 16, 2026
The company is K.C. Pharmaceuticals of California. The FDA's table lists eight recalls (D-0002-2027 through D-0009-2027), all Class II. Seven have listed quantities that add up to 4,848,342 cartons, and the eighth is marked N/A. That matches the total from the Dry Eye Foundation, a nonprofit that runs eyedropsafety.org. Class II covers products that may cause temporary or medically reversible health problems, and it is not the agency's most serious level.
What is affected
The eight products are artificial tears, dry eye and lubricating drops, and redness relievers, all in 0.5-ounce bottles. The table names private and store labels including Best Choice, Leader, Equaline, Good Sense, Harris Teeter and Discount Drug Mart, plus military exchange labels. The Healthy counts 27 brands in all, among them Walgreens, Kroger, Publix and Target's up&up. Those four do not appear in the part of the table WECU News reviewed, because the brand lists are cut off.
Whether a bottle is recalled depends on its lot number and expiration date, not only the brand. The lots visible in the table expire from Nov. 30, 2026 to Nov. 30, 2027, and the full lists are on the FDA page. Examples include AT25B01, LT25B01 and SU25B01, each expiring Feb. 28, 2027.
What the risk is
"Lack of assurance of sterility" means the company cannot guarantee the drops are free of microbes. None of the reports WECU News reviewed describes confirmed infections tied to these lots. The Dry Eye Foundation's summary lists no adverse events, and WECU News found no FDA statement on illnesses.
The maker's record
The recalled drops were made at the company's own plant in Pomona, California, where the FDA's warning letter says the problems were found. Product labels read "Manufactured... By K.C Pharmaceuticals, Inc., Pomona, CA." The FDA inspected that plant from Jan. 20 to Feb. 13, 2026. In an Aug. 12 warning letter, the agency said the firm "lacked timely and adequate media fill investigations." A media fill is a test that simulates sterile filling to see whether microbes get in, and the letter lists failures on three dates in 2024. The FDA also said the firm "continued to manufacture and release sterile drug products" after those failures.
The letter says the company committed to suspending its over-the-counter drug production and must notify the FDA before resuming. It also cites repeat violations from an Aug. 3, 2023 warning letter.
This is not the first large recall from the company this year. In March it recalled more than 3.1 million bottles for the same stated reason, and the FDA classified that recall as Class II on March 31.
What is not known
The FDA record says no press release was issued for this recall, and WECU News did not find a statement from K.C. Pharmaceuticals. It is also not clear how the October recall relates to the one in March. The FDA page has the full brand and lot lists. A pharmacist or eye doctor can advise on a replacement, and anyone with eye pain, redness or vision changes after using a drop should contact an eye doctor.
Sources:
Dry Eye Foundation (eyedropsafety.org): 5 million units recalled by KC Pharma due to lack of assurance of sterility (Oct. 2026). Nonprofit; its total matches the FDA table.
Newsweek: Millions of Eye Drops Recalled Nationwide Amid Safety Fears (2026), for the March recall
Topics:eye drop recallK.C. Pharmaceuticalslack of assurance of sterilityFDA recallartificial tears recalldry eye dropsredness relief dropsFDA warning letterstore brand eye dropslot numbers
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