A California drugmaker is voluntarily recalling more than 3.1 million bottles of over-the-counter eye drops over concerns about sterility. The Food and Drug Administration documented the recall after K.C. Pharmaceuticals distributed the products through major retailers including Walgreens, Kroger and CVS. The recall was initiated on March 3 and formally classified by the FDA on March 31.
Officials say there are no reported illnesses tied to these products, but the recall was issued because the manufacturer could not assure sterility. The FDA labeled the action a Class II recall, meaning use of the products may cause temporary health effects but serious outcomes are unlikely.
Recalled products
– Sterile Eye Drops AC
– Eye Drops Advanced Relief
– Dry Eye Relief Eye Drops
– Ultra Lubricating Eye Drops
– Sterile Eye Drops Original Formula
– Sterile Eye Drops Redness Lubricant
– Sterile Eye Drops Soothing Tears
– Artificial Tears Sterile Lubricant Eye Drops
Consumers who have any of the listed products are advised to stop using them and discard them. CVS said the four items it sold were discontinued nearly a year ago and that customers can return affected products for a refund. Other retailers are managing the recall and directing customers on next steps.
Experts emphasize that while no infections have been reported, recalls can undermine public confidence in medications. Gary Novack, PhD, a clinical professor and ophthalmic product consultant, noted that the recall reflects uncertainty — the manufacturer reported a sterility issue, but there’s no confirmed contamination or identified microbe. Sylvia Groth, MD, an ophthalmologist and medical director, said recalls worry clinicians because they can erode trust and complicate future treatment recommendations.
Prescription eye drops are not included in this recall; patients should continue using prescribed medications for glaucoma, dry eye, infections or other conditions unless told otherwise.
Background and risk factors
Health officials point to past incidents where contaminated eye drops caused serious infections. A 2023 outbreak linked to tainted eye drops led to more than 80 infections and four deaths in the U.S.; investigations found contamination with antibiotic-resistant Pseudomonas aeruginosa and manufacturing lapses. Experts have noted that temporary pauses in FDA inspections during the COVID-19 pandemic may have allowed some manufacturing problems to go undetected.
Signs of possible eye infection
If you used one of the recalled products and develop symptoms, seek medical attention. Watch for:
– Eye discharge
– Pain or discomfort
– Redness or inflammation
– Blurry or decreased vision
Those symptoms can also reflect allergies or other noninfectious conditions, so monitor how symptoms evolve and consult a clinician if they worsen or do not improve. Contact lens wearers are at higher risk for complications because lenses can cause small abrasions and harbor bacteria.
How to reduce risk when using eye drops
– Wash your hands before applying drops.
– Avoid letting the tip of the bottle touch your eye, eyelashes or any surface.
– Discard single-use vials immediately after use.
– Choose reputable brands or follow a doctor’s recommendation.
If you’re concerned you may have used a recalled product or are experiencing symptoms, contact your healthcare provider or local pharmacy for guidance.
